eye on it qualifications pack - occupational … · 2018-01-10 · kb5. scale-up and post-approval...

h

Contents 1. Introduction and Contacts..….……….…….P.1

2. Qualifications Pack……….………………........P.2

3. Glossary of Key Terms ….……………..........P.4

4. NOS Units………………………..….……..………..P.6

5. Annexure: Nomenclature for QP & OS….P.33

6. Assessment Criteria………………………………P.35

technology consul t ing

OS describe what

individuals need to do, know and understand in order to carry out a particular job role or function

OS are

performance standards that individuals must achieve when carrying out functions in the workplace, together with specifications of the underpinning knowledge and understanding

Life Sciences Sector Skill Development Council 13, Palam Marg, 3rd Floor, Vasant Vihar, New Delhi, 110057 Phone No.: +91 11 41042407/408 E-mail: [email protected]

Qualifications Pack-Research Associate Technology

Transfer /Process Development SECTOR: LIFE SCIENCES

SUB-SECTOR: PHARMACEUTICAL AND BIOPHARMACEUTICAL

OCCUPATION: RESEARCH AND DEVELOPMENT

REFERENCE ID: LFS/Q0511

ALIGNED TO: NCO-2004/NIL

Research Associate Technology Transfer/Process Development is responsible to research and devise ways to manufacture products and monitor existing processes and products for quality and efficiency, data analysis; and writing and disseminating research results.

Brief Job Description: Research Associate - Technology Transfer/Process Development assists in technology transfer to large scale manufacturing and is responsible for carrying out research related activities along with its reporting and documentation.

Personal Attributes: The individual should have definitive and comprehensive understanding of research project being undertaken. He/ She should have working knowledge of research study design, hypothesis testing and qualitative data interpretation.

EYE ON IT Current Industry Trends

Suscipit, vicispraesent erat

feugaitepulae, validus indoles

duis enimconsequatgenitus at.

Sed, conventio, aliquip

accumsanadipiscingaugueblan

dit minim abbasoppetocommov.

Enim neo velitadsumodio,

multo, in

commoveoquibuspremotamene

rathuic.Occuro uxor dolore, ut

at praemittooptosisudo,

opesfeugiatiriurevalidus.Sino

lenis vulputate,

valetudoilleabbascogosaluto

quod, esseillum,

letatioloremconventio.Letalisnib

hiustumtransverbero bene, erat

vulputateenim esse si sudo

erat.

SOFTWARE Monthly Picks

Volutpatmos at

neque

nullalobortis

dignissim

conventio, torqueo, acsi roto

modo. Feugait in

obruoquaeingenium tristique

elitvelnatumeus.

Moliortorqueocapiovelitloquorap

tentuteratfeugiatpneumcommod

o.

Enim neo velitadsumodio,

multo, in

commoveoquibuspremotamene

rathuic.Occuro uxor dolore, ut

at praemittooptosisudo,

opesfeugiat.

Aptentnullaaliquipcamurut

consequataptentnisl in voco

consequat.Adipsdiscing magna

jumentumvelitiriureobruo.damnum

pneum.

Aptentnullaaliquipcamurutconsequatl

oremaptentnisl magna

jumentumvelitan en iriure. Loquor,

vulputatemeusindolesiaceo, ne

secundum,

dolusdemoveointerddficoproprius.In

consequatosquadfsenudflla

magna.Aptentnullaaliquipcamurutans

dl as consequataptentnisl in

vocolocconsequatispo facto delore

ergo maskaforgeuitmascapala ergo

sacrum lamap

allacumdergo ipso aliquipmiasermi

proprius. quaenulla magna. Delenitabdo esse quia, te

huic. Ratisnequeymo, venioillum

paladamnum. Aptentnullaaliquipcamur ut

consequataptent. Adipiscing magna jumentum

velitiriureobruovel.Volutpat mos atnequenulla

modo. Feugait in obruoquaeingenium tristique

elitvelnatu meus. Moliortorqueocapiovelitloquor

aptent ut erat feugiatpneumcommodovelobruomara

duis enimconsequatgenitus. Enim neo velitadsumodio,

multolorem ipso matairlosa.

Introduction

QUALIFICATIONS PACK - OCCUPATIONAL STANDARDS FOR LIFE SCIENCES INDUSTRY

Qualifications Pack For Research Associate Technology Transfer /Process Development

2 | P a g e

Qualifications Pack Code LFS/Q0511

Job Role Research Associate -Technology Transfer/Process Development

Credits(NSQF) TBD Version number 1.0

Sector Life Sciences Drafted on 15/12/14

Sub-sector

Pharmaceutical and Biopharmaceutical

Last reviewed on 25/02/15

Occupation Research and Development

Next review date 01/06/17

NSQC Clearance on 20/07/2015

Job Role Research Associate Technology Transfer /Process Development

Role Description

Responsible for technology transfer/process development and is responsible for carrying out research related activities along with its reporting and documentation

NSQF level Minimum Educational Qualifications Maximum Educational Qualifications

5

Masters in relevant discipline/ M. Pharma

Doctorate in any discipline of Life Sciences, Pharmaceutics (Preferable)

Training (Suggested but not mandatory)

On the job training

Minimum Job Entry Age 22 Years

Experience

Fresher, 1-2 years’ experience preferred

Applicable National Occupational Standards (NOS)

Compulsory 1 LFS/N0517: Assist in technology transfer/process

development

2 LFS/N0513: Carry out reporting and documentation

for research activities

3 LFS/N0514: Assist in planning and communicating

research activities


3 | P a g e

4 LFS/N0515: Undertake initiative, problem solving and

decision-making

5 LFS/N0101: Maintain a healthy, safe and secure

working environment in the life sciences facility

6 LFS/N0104: Co-ordinate with supervisor and team

members

Optional N.A.

Performance Criteria As described in the relevant NOS units

Job

Det

ails


4 | P a g e

Keywords /Terms Description

Core Skills/Generic Skills

Core Skills or Generic Skills are a group of skills that are key to learning and working in today's world. These skills are typically needed in any work environment. In the context of the NOS, these include communication related skills that are applicable to most job roles.

Description Description gives a short summary of the unit content. This would be helpful to anyone searching on a database to verify that this is the appropriate NOS they are looking for.

Function

Function is an activity necessary for achieving the key purpose of the sector, occupation, or area of work, which can be carried out by a person or a group of persons. Functions are identified through functional analysis and form the basis of NOS.

Job role

Job role defines a unique set of functions that together form a unique employment opportunity in an organisation.

Knowledge and Understanding

Knowledge and Understanding are statements which together specify the technical, generic, professional and organisational specific knowledge that an individual needs in order to perform to the required standard.

National Occupational Standards (NOS)

NOS are Occupational Standards which apply uniquely in the Indian context.

Occupation

Occupation is a set of job roles, which perform similar/related set of functions in an industry.

Organisational Context

Organisational Context includes the way the organisation is structured and how it operates, including the extent of operative knowledge managers have of their relevant areas of responsibility.

Performance Criteria

Performance Criteria are statements that together specify the standard of performance required when carrying out a task.

Qualifications Pack(QP)

Qualifications Pack comprises the set of NOS, together with the educational, training and other criteria required to perform a job role. A Qualifications Pack is assigned a unique qualification pack code.

Qualifications Pack Code

Qualifications Pack Code is a unique reference code that identifies a qualifications pack.

Scope

Scope is the set of statements specifying the range of variables that an individual may have to deal with in carrying out the function which have a critical impact on the quality of performance required.

Sector Sector is a conglomeration of different business operations having similar businesses and interests. It may also be defined as a distinct subset of the economy whose components share similar characteristics and interests.

Def

init

ion

s


5 | P a g e

Sub-Sector Sub-sector is derived from a further breakdown based on the characteristics and interests of its components.

Sub-functions

Sub-functions are sub-activities essential to fulfil the achieving the objectives of the function.

Technical Knowledge

Technical Knowledge is the specific knowledge needed to accomplish specific designated responsibilities.

Unit Code

Unit Code is a unique identifier for an NOS unit, which can be denoted with an ‘N’.

Unit Title

Unit Title gives a clear overall statement about what the incumbent should be able to do.

Keywords /Terms Description

NOS National Occupational Standard(s)

NSQF National Skill Qualifications Framework

NCO-2004 National Classification of Occupations-2004

OS Occupational Standard(s)

QP Qualifications Pack

SOP Standard Operating Procedure(s)

DNA Deoxy Ribonucleic Acid

CPP Certificate of Pharmaceutical Product

CQA Critical Quality Attributes

GMP Good Manufacturing Practices

GLP Good Laboratory Practices

Acr

on

yms

LFS/N0517 : Assist in technology transfer /process development

6 | P a g e

National Occupational

Standard

Overview

This Occupational Standard describes the knowledge, understanding and skills required for a Research Associate Technology Transfer/ Process Development to assist in Technology Transfer /process development activities .

LFS/N0517 : Assist in technology transfer/process development

7 | P a g e

Unit Code LFS/N0517

Unit Title (Task)

Assist in technology transfer / process development

Description This NOS is about a Research Associate Technology Transfer/ Process Development assisting in technology transfer/ process development activities

Scope

This unit / task covers the following:

Technology transfer activities

Activities to be carried out during research process

Performance Criteria (PC) w.r.t. the Scope

Element


Technology Transfer activities

To be competent, the user/individual on the job must be able to:

PC1. devise ways to produce the new product on a large scale with standardized protocols and support in technology transfer

PC2. research and develop ways to manufacture products and monitor existing processes and products for quality and efficiency

PC3. asses the manufacturer’s information like raw materials, critical process parameters, performing equipment and comparisons

PC4. evaluate the process development for its robustness PC5. review packaging line trials, e.g. if a product is a new SKU to the plant/site it is

crucial to perform line trials for filling the product into the proposed bottle/ container

PC6. review stability indicating methods to enable onsite transfer against the protocol signed off by the client/manufacturer/ R&D team

PC7. review validation records for the small scale batch produced PC8. crosscheck safety handling protocols for the product


PC9. devise ways to make improvements in methods and technology by reviewing and interpreting technical test results and data

PC10. use sophisticated technology to monitor and identify faults in the production process

PC11. work closely with cross functional teams from Operations, Tech Operations, CMC, Supply Chain, Analytical, Quality, R&D etc.

PC12. Identification/verification of CPPs and CQAs and other important parameters. PC13. verify design space and understand set of input ranges (CPPs) that provide high

probability that CQAs will meet specification PC14. support the control strategy to assure focus on critical points PC15. assurance of clear documentation of all process/product knowledge PC16. work with the integrated interdisciplinary team of experts: Operations, Tech

Operations, CMC, Supply Chain, Analytical, Quality, R&D etc.

Knowledge and Understanding (K)

A. Organisational Context (Knowledge of the

The user/individual on the job needs to know and understand: KA1. the reason and impact of the occurrence of problems during research work

Nat

ion

al O

ccu

pat

ion

al S

tan

dar

d


8 | P a g e

Company/ Organisation and its processes)

KA2. measures, steps and possible solutions that have been taken/identified to address the previous problems

KA3. the correct method for carrying out corrective actions outlined for each problem

KA4. knowledge of competitor products KA5. in-depth knowledge of organisation products and their benefits vis-à-vis

competition

B. Technical Knowledge

The user/individual on the job needs to know and understand: KB1. understanding of prior knowledge from similar products KB2. manufacturer’s information: from raw materials through critical process

parameters, followed by performing equipment, backsides, and comparisons KB3. GLP and GMP KB4. need and relevance for technology transfer KB5. Scale-Up and Post-Approval Change (SUPAC) guidelines along with FDA

guidelines which identify the types of equipment available for different pharmaceutical manufacturing functions

KB6. ideal technology transfer conditions where equipment should stay within the same class or sub-class, eliminating unnecessary variables

KB7. broad reasons for questioning during FDA pre-approval reviews and annual reports

KB8. Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs) KB9. process parameters and process capability KB10. manufacturing and process control technologies along with quality systems

infrastructure KB11. concept of pilot vs. manufacturing scale KB12. product/process/analytical method knowledge between development and

manufacturing sites KB13. knowledge of SOPs and protocols KB14. product life cycle knowledge and understanding KB15. knowledge of manufacturing process KB16. technical reasons for manufacturing defects KB17. Uni-variant/Multi-variant Design of experiments KB18. validation requirements/strategy

Skills (S)

A. Core Skills/ Generic Skills

Writing Skills

The user/ individual on the job needs to know and understand how to: SA1. make complete and accurate notes of the information and data gathered SA2. record and communicate details of work done to appropriate people SA3. excellent report writing skills both offline (pen and paper) and online using

computer based system

Reading Skills


9 | P a g e

The user/individual on the job needs to know and understand how to: SA4. follow guidelines/procedures/rules and service level agreements SA5. Read and interpret memos/ instructions. SOPs

Oral Communication (Listening and Speaking Skills)

The user/individual on the job needs to know and understand how to: SA4. communication with upstream and downstream teams SA5. listen effectively and orally communicate information accurately

B. Professional Skills

Decision Making

The user/individual on the job needs to know and understand how to: SB1. make decisions on a suitable course of action or response SB2. apply balanced judgments to different approaches

Plan and Organise

The user/individual on the job needs to know and understand how to: SB3. plan work assigned on a daily basis to complete the work in time and provide

estimates of time required for each piece of work

Problem Solving

The user/individual on the job needs to know and understand how to: SB4. seek clarification on problems from supervisors SB5. use effective problem solving techniques

Analytical Thinking

The user/individual on the job needs to know and understand how to: SB6. analyse data and activities

SB7. pass on relevant information to other departments SB8. give attention to detail

Critical Thinking

The user/individual on the job needs to know and understand how to: SB9. provide opinion on work in a detailed and constructive way

Customer Centricity

Not Applicable


10 | P a g e

NOS Version Control

NOS Code LFS/N0517


Industry Life Sciences Drafted on 15/12/14

Industry Sub-sector Pharmaceutical and Biopharmaceutical


Occupation R&D Next review date 01/06/17

LFS/N0513 : Carry out reporting and documentation for research activities

11 | P a g e

Overview

This Occupational Standard describes the knowledge, understanding and skills required for a Research Associate Technology Transfer /Process Development to carry out reporting and documentation for research activities.


Standard


12 | P a g e

Unit Code LFS/N0513

Unit Title (Task)

Carry out reporting and documentation for research activities

Description This NOS is about a Research Associate Technology transfer /Process Development carrying out reporting and documentation for research activities

Scope

The unit/task covers the following:

Pre research activities


Post research activities


Element


Pre research activities To be competent, the user/individual on the job must be able to:

PC1. develop research objectives and proposals for own or joint research PC2. translate knowledge of advances in the subject area into research activity PC3. assist in the preparation of proposals and applications to external bodies, e.g.

for funding and contractual purposes


PC4. conduct individual and collaborative research projects PC5. write up research work for presentation and publication PC6. record details accurately in appropriate format in adherence with

confidentiality and intellectual property rights (IPR) guidelines of organization PC7. continually update knowledge and understanding in field or specialism PC8. manage own research and administrative activities, with guidance if required PC9. validating the research information at regular cycles PC10. provide updates and status reports to senior management on a regular basis;

report on performance against plan

Post research

activities

PC11. interpret the research results correctly PC12. ensure that the final document meets regulatory and compliance requirements PC13. make sure documents are available to all appropriate authorities to inspect PC14. make presentations


B. Organisational Context (Knowledge of the Company/ Organisation and its processes)

The user/individual on the job needs to know and understand: KA1. all relevant Standard Operating Procedures(SOPs) and coding systems of the

company KA2. institutional and professional code of ethics and standards of practice KA3. privacy policy and Intellectual Property Rights (IPR) rules of the company KA4. safety and health policies and regulations for the workplace KA5. communication hierarchy, procedures and escalation matrix as well as

individual responsibility for reporting and documentation


The user/individual on the job needs to know and understand:

Nat

ion

al O

ccu

pat

ion

al S

tan

dar

d


13 | P a g e

KB1. knowledge on different standard reference material KB2. knowledge of drugs, products, side effects, adverse reactions, process

knowledge, Good Laboratory practices and Good Manufacturing practices KB3. statistical analysis of test data KB4. methods and procedures of writing and maintaining lab and research records in

off line (pen and paper) and computer based systems KB5. research reports, schemes and guidelines

Skills (S)


Writing Skills

The user/ individual on the job needs to know and understand how to: SA1. make complete and accurate notes of the information and data gathered SA2. excellent report writing skills both offline (pen and paper) and online using

computer based system SA3. write e-mails, power point presentations, table, charts and Ms word

documents

Reading Skills

The user/individual on the job needs to know and understand how to: SA4. follow guidelines/procedures/rules and service level agreements

Oral Communication (Listening and Speaking Skills)

The user/individual on the job needs to know and understand how to: SA5. interact with people to effectively gather information SA6. listen effectively and orally communicate information accurately SA7. ask for clarification and advice from others


Decision Making

The user/individual on the job needs to know and understand how to: SB1. make decisions on a suitable course of action or response SB2. apply balanced judgments to different approaches

Plan and Organise

The user/individual on the job needs to know and understand how to: SB3. plan work assigned on a daily basis to complete the work in time and provide

estimates of time required for each piece of work

Problem Solving

The user/individual on the job needs to know and understand how to: SB4. seek clarification on problems from supervisors SB5. use effective problem solving techniques

Analytical Thinking


14 | P a g e


SB7. pass on relevant information to other departments SB8. apply arithmetic and mechanical skills

Critical Thinking

The user/individual on the job needs to know and understand how to: SB9. provide opinions on work in a detailed and constructive way

Customer Centricity

Not Applicable

NOS Version Control

NOS Code LFS/N0513


Industry Life Sciences Drafted o n 15/12/14




LFS/N0514 : Assist in planning and communicating research activities

15 | P a g e

Overview

This Occupational Standard describes the knowledge, understanding and skills

required of a Research Associate Technology Transfer /Process Development to

plan and communicate research activities.


Standard


16 | P a g e

Unit Code LFS/N0514

Unit Title (Task)

Assist in planning and communicating research activities

Description This NOS unit is about a Research Associate Technology Transfer /Process Development assisting in planning and communicating research activities

Scope


Planning research activities

Communicating research activities

Performance Criteria (PC) w.r.t the Scope

Element


Planning research activities

To be competent, the user/individual on the job must be able to:

PC1. assist in planning the use of research resources, laboratories and workshops as appropriate

PC2. assist in planning and managing own research activity in collaboration with others

PC3. contribute to the planning of research projects

Communicating research activities

PC4. prepare papers for steering groups and other bodies PC5. communicate material of a specialist or highly technical nature to principal

investigator. PC6. contribute to the production of research reports and publications PC7. deal with routine communication using a range of media PC8. present information on research progress and outcomes to bodies supervising

research, e.g. steering groups


A. Organisational Context (Knowledge of the Company/ Organisation and its processes)

The user/individual on the job needs to know and understand: KA1. potential hazards, actions to minimize the same and basic disaster

management KA2. institutional and professional code of ethics and standards of practice KA3. equipment used in the process and their function

B Technical Knowledge

The user/individual on the job needs to know and understand: KB1. inspection or test points (control points) in the process and the related

procedures and recording requirements KB2. knowledge of basic laboratory procedures, including pipetting , DNA and

histology

Skills (S)

Writing Skills

Nat

ion

al O

ccu

pat

ion

al S

tan

dar

d


17 | P a g e


The user/ individual on the job needs to know and understand how to: SA1. complete documentation accurately

Reading Skills

The user/individual on the job needs to know and understand how to: SA2. read and understand manuals, SOPs, health and safety instructions, memos,

reports, job cards etc.

Oral Communication (Listening and Speaking skills)

The user/individual on the job needs to know and understand how to: SA3. communication with upstream and downstream teams


Decision Making

The user/individual on the job needs to know and understand how to: SB1. resolve any difficulties in relationships with colleagues , or get help from an

appropriate person, in a way that preserves goodwill and trust

Plan and Organise

The user/individual on the job needs to know and understand how to: SB2. plan research on a regular basis SB3. provide estimates of time required for each research

Analytical Thinking

The user/individual on the job needs to know and understand how to: SB4. give attention to detail

Problem Solving

The user/individual on the job needs to know and understand how to: SB5. identify immediate or temporary solutions to resolve delays SB6. comprehend the problem, identify the solution(s) and suggest the best possible

solution to the customer

Critical Thinking

The user/individual on the job needs to know and understand how to: SB7. suggest improvements(if any) in process based on experience

Customer Centricity

Not Applicable


18 | P a g e

NOS Version Control

NOS Code LFS/N0514






LFS/N0515 : Undertake initiative, problem solving and decision-making

19 | P a g e

Overview

This Occupational Standard describes the knowledge, understanding and skills required of a Research Associate Technology Transfer /Process Development to initiate, solve problem and make decisions


Standards


20 | P a g e

Unit Code LFS/N0515

Unit Title (Task)

Undertake initiative, problem solving and decision-making

Description This NOS unit is about the Research Associate Technology Transfer /Process Development taking initiative, solving problems and making decisions

Scope


Initiate research activities

Problem solving

Contribute to team decisions


Element


Initiate To be competent, the user/individual on the job must be able to: PC1. use new research techniques and methods in adherence to organizational

SOPs

PC2. use initiative and creativity to identify areas for research, develop new

research methods and extend the research portfolio

PC3. use creativity to analyze and interpret research data and draw conclusions on the outcomes

Problem solving PC4. deal with problems which may affect the achievement of research objectives PC5. analyse and interpret the results of own research and generate original ideas

Decision-making PC6. contribute to decisions affecting the work of the team PC7. contribute to collaborative decision making with colleagues



The user/individual on the job needs to know and understand: KA1. safety guidelines to be adhered to while carrying out research KA2. documentation requirements for research activities KA3. institutional and professional code of ethics and standards of practice KA4. approval process and guidelines for getting research approved


The user/individual on the job needs to know and understand: KB1. importance of compliance with company protocols while carrying out research

Skills (S)

Writing Skills

Nat

ion

al O

ccu

pat

ion

al S

tan

dar

d


21 | P a g e


The user/ individual on the job needs to know and understand how to: SA1. record relevant information pertaining to the research in a format which is

understandable and useable

Reading Skills

The user/individual on the job needs to know and understand how to: SA2. read notes/comments from supervisors SA3. read and interpret SOPs and regulatory instructions/ manuals


The user/individual on the job needs to know and understand how to:

SA4. communicate effectively with the team members and supervisors


Decision Making

The user/individual on the job needs to know and understand how to: SB1. make decisions in a team considering the ideas of the team SB2. make decisions on a suitable course of action or response

Plan and Organise

The user/individual on the job needs to know and understand how to: SB3. plan the research within timeline and budget

Critical Thinking

The user/individual on the job needs to know and understand how to: SB4. provide inputs on agenda for the research so as to keep it aligned with the

interest of all the team members

Problem Solving

The user/individual on the job needs to know and understand how to: SB5. effectively solve problems while organizing SB6. think through problems, evaluate the possible solution(s) and suggest an

optimum /best possible solution(s) SB7. identify immediate or temporary solutions to resolve delays Analytical Thinking

The user/individual on the job needs to know and understand how to: SB8. analyse options during research process to optimize costs and research

resources SB9. give attention to detail

Customer Centricity

Not Applicable


22 | P a g e

NOS Version Control

NOS Code LFS/N0515






LFS/N0101 : Maintain a healthy, safe and secure working environment in the life sciences facility

23 | P a g e


Standard

Overview

This Occupational Standard describes the knowledge, understanding and skills required for a Research Associate Technology Transfer /Process Development for ensuring healthy, safe and secure working environment in the life sciences facility.


24 | P a g e

Unit Code LFS/N0101

Unit Title (Task)

Maintain a healthy, safe and secure working environment in the life sciences facility

Description This NOS unit is about a Research Associate Technology Transfer /Process Development monitoring the working environment and making sure it meets the requirements for health, safety and security in the pharmaceutical research facility /testing/ analysis or research laboratory.

Scope

Ensuring healthy, safe and secure working environment:

self monitor and adhere to safety principles and standards

ensure behavioural safety by workmen to cGMP and applicable safety standards on the shop floor/ laboratory

report any identified breaches in health, safety, and security policies and procedures to the designated person

Managing emergency procedures:

Illness

Accidents

Fires

Other reasons to evacuate the premises

Breaches of security


Element


Ensuring healthy, safe and secure working environment

To be competent, the user/individual on the job must be able to: PC1. observe and comply with the company’s current health, safety and security

policies and procedures

PC2. while carrying out work, use appropriate safety gears like head gear, masks,

gloves and other accessories as mentioned in the guidelines

PC3. report any identified breaches in health, safety, and security policies and

procedures to the designated person

PC4. responsible for maintaining discipline at the shop-floor/ production area

PC5. identify and correct any hazards that the individual can deal with safely,

competently and within the limits of their authority

PC6. adhere and comply to storage and handling guidelines for hazardous material

PC7. identify and recommend opportunities for improving health, safety, and

security to the designated person

PC8. complete any health, safety and security activities like safety drills and prepare

records legibly and accurately

Managing emergency procedures

PC9. report any hazards that you are not competent to deal with to the relevant person in line with organizational procedures and warn other people who may be affected

PC10. follow your company’s emergency procedures promptly, calmly, and efficiently


Nat

ion

al O

ccu

pat

ion

al S

tan

dar

d


25 | P a g e


The user/individual on the job needs to know and understand: KA1. legislative requirements and company’s procedures for health, safety and

security and your role and responsibilities in relation to this

KA2. what is meant by a hazard, including the different types of health and safety

hazards that can be found in the workplace

KA3. how and when to report hazards

KA4. limits of your responsibility for dealing with hazards

KA5. your organization’s emergency procedures for different emergency situations

and the importance of following these

KA6. the importance of maintaining high standards of health, safety and security

KA7. implications that any non-compliance with health, safety and security may have on individuals and the organization

KA8. health hazards and its implications if any in the production process


The user/individual on the job needs to know and understand:

KB1. different types of breaches in health, safety and security and how and

when to report these

KB2. evacuation procedures for workers and visitors

KB3. how to summon medical assistance and the emergency services, where

necessary

KB4. how to use the health, safety and accident reporting procedures and the

importance of these

KB5. KB6.

different types of occupational health hazards

KB6. knowledge of chemical substances, their characteristics and required

precaution and safety measures

Skills (S)


Writing Skills

The user/individual on the job needs to know and understand how to: SA1. complete accurate, well written work with attention to detail

Reading Skills

The user/individual on the job needs to know and understand how to: SA2. read instructions, guidelines, procedures, rules and service level agreements


The user/individual on the job needs to know and understand how to: SA3. listen effectively and orally communicate information accurately


26 | P a g e


Decision Making

The user/individual on the job needs to know and understand how to: SB1. make decisions on suitable courses of action

Plan and Organise

The user/individual on the job needs to know and understand how to: SB2. plan and organize your work to meet health, safety and security requirements

Problem Solving

The user/individual on the job needs to know and understand how to: SB3. apply problem solving approaches in different situations

Analytical Thinking


Critical Thinking

The user/individual on the job needs to know and understand how to: SB5. apply balanced judgments to different situations

Customer Centricity

Not Applicable

NOS Version Control

NOS Code LFS/N0101



Industry Sub-sector Pharmaceuticals and Bio Pharmaceuticals


Occupation Manufacturing, Quality, Supply Chain, R&D


v LFS/N0104 : Coordinate with Supervisor and team members

27 | P a g e


Standards

Overview

This Occupational Standard describes the knowledge, understanding and skills required for a Research Associate Technology Transfer /Process Development to co-ordinate with manager and team members.


28 | P a g e

Unit Code LFS/N0104

Unit Title (Task)

Coordinate with Supervisor and team members

Description This NOS unit is about a Research Associate Technology Transfer /Process Development working with the team and the manager for carrying out research activities.

Scope

This unit/task covers the following: Coordinate with supervisor

receive work instructions from reporting supervisor

communicate to reporting supervisor about process-flow improvements, production defects received from previous process, repairs and maintenance of equipment as required

provide support to supervisor for carrying out investigations related to complaints, batch failures, OOS/ OOT, incidents etc.

communicate any potential hazards or expected process disruptions

provide requisite information, documents, clarifications to supervisor during actual audits

handover completed work to supervisor Coordinate with team members

work as a team with colleagues and share work as per their or own work load and skills

interview team members and colleagues to collect data to be recorded in log books and batch documents

support/assign personnel/team members to support internal and external audit activities as per instructions of superiors/supervisor

work with colleagues of other departments

communicate and discuss work flow related difficulties in order to find solutions with mutual agreement

provide documented shift handovers to the next person in the shift


Element


Coordination with manager

To be competent, the user/individual on the job must be able to carry out: PC1. understand the work output requirements PC2. comply with company policy and rule PC3. proactively inform supervisor on issues requiring intervention PC4. deliver quality work on time and report any anticipated reasons for delays

Coordination with team members

PC5. put team over individual goals PC6. be able to resolve conflicts PC7. learn how to multi-task relevant activities PC8. impart training to team members/cross-function team members


Nat

ion

al O

ccu

pat

ion

al S

tan

dar

d


29 | P a g e

B. Organisational Context (Knowledge of the Company/ Organisation and its processes)

The user/individual on the job needs to know and understand: KA1. knowledge of process management. KA2. the correct method for carrying out corrective actions outlined for each

problem. KA3. escalation matrix for reporting identified issues KA4. implications of not adhering to quality control procedures (pertaining to call

audits by quality analysts for the executives). KA5. company’s tie-ups with technical bodies


The user/individual on the job needs to know and understand: KB1. domain knowledge pertaining to life sciences industry.

KB2. benefits of the product with respect to similar products from other companies

KB3. application of basic sciences (chemistry), mathematics

KB4. commercial awareness of pharmaceutical products and overall healthcare

sector

Skills (S)


Writing Skills

The user/ individual on the job needs to know and understand how to: SA1. report/observation writing skills

Reading Skills

The user/individual on the job needs to know and understand how to: SA2. read notes/comments from the supervisor SA3. read job sheets and interpret technical details mentioned in the jobsheet


The user/individual on the job needs to know and understand how to: SA3. interact with team members to work efficiently


Decision Making

The user/individual on the job needs to know and understand how to: SB1. spot and communicate potential areas of disruptions to work process and

report the same SB2. when to report to supervisor and when to deal with a colleague individually,

depending on the type of concern

Problem Solving

The user/individual on the job needs to know and understand how to: SB3. improve work processes by interacting with others and adopting best practices


30 | P a g e

Critical Thinking

The user/individual on the job needs to know and understand how to: SB4. spot process disruptions and delays and report and communicate with solutions

Plan and Organise

Not Applicable

Analytical Thinking

Not Applicable

Customer centricity

Not Applicable

NOS Version Control

NOS Code LFS/N0104



Industry Sub-sector Pharmaceuticals and Bio Pharmaceuticals


Occupation Manufacturing, Quality, Supply Chain, R&D


Q

Qualification Pack for Research Associate Technology Transfer /Process Development

31 | P a g e

Annexure

Nomenclature for QP and NOS

Qualifications Pack

9 characters

LFS/ Q 0101

LFS QP Number (2 numbers)

Q denoting Qualification Pack Occupation (2 numbers)

Occupational Standard

An example of NOS with ‘N’

9 characters

LFS/ N 0101

LFS OS Number (2 numbers)

Occupation (2 numbers)

N denoting National Occupational Standard

Q


32 | P a g e

The following acronyms/codes have been used in the nomenclature above:

Sub-Sector Range of Occupation Numbers

Pharmaceutical and Biopharmaceutical and Contract Research

01-10

Pharmaceutical 11-20

Biopharmaceutical 21-30

Contract Research 31-40

Sequence Description Example

Three letters Industry name LFS

Slash / /

Next letter Whether QP or NOS Q/N

Next two numbers Occupation code 01

Next two numbers OS number 01

Q


33 | P a g e

CRITERIA FOR ASSESSMENT OF TRAINEES

Job Role Research Associate Technology Transfer /Process Development Qualification Pack LFS/Q0511 Sector Skill Council Life Sciences Sector Skill Development Council

Guidelines for Assessment: 1. Criteria for assessment for each Qualification Pack will be created by the Sector Skill Council. Each Performance Criteria (PC) will be assigned marks proportional to its importance in NOS. SSC will also lay down proportion of marks for Theory and Skills Practical for each PC. 2. The assessment for the theory part will be based on knowledge bank of questions created by the SSC. 3. Individual assessment agencies will create unique question papers for theory part for each candidate at each examination/training center (as per assessment criteria below) 4. Individual assessment agencies will create unique evaluations for skill practical for every student at each examination/training center based on this criteria 5. To pass the Qualification Pack , every trainee should score a minimum of 70% in every NOS 6. In case of successfully passing only certain number of NOS's, the trainee is eligible to take subsequent assessment on the balance NOS's to pass the Qualification Pack.

Marks Allocation

Assessment Outcome

Assessment Criteria of Outcomes

Total Marks (600)

Out of Theory Practical

LFS/N0517 (Assist in

Technology Transfer /Process

Development)

PC1. devise ways to produce the new product on a large scale with standardized protocols and support in technology transfer

100

7 3 4

PC2. research and develop ways to manufacture products and monitor existing processes and products for quality and efficiency

6 3 3

PC3. assess the manufacturer’s information like raw materials, critical process parameters, performing equipment and comparisons

7 3 4

PC4. evaluate the process development for its robustness

6 3 3

Q


34 | P a g e

PC5. review packaging line trials, e.g. if a product is a new SKU to the plant/site it is crucial to perform line trials for filling the product into the proposed bottle/ container

6 3 3

PC6. review stability indicating methods to enable onsite transfer against the protocol signed off by the client/manufacturer/ R&D team

6 3 3

PC7. review validation records for the small scale batch produced

6 3 3

PC8. crosscheck safety handling protocols for the product

6 3 3

PC9. devise ways to make improvements in methods and technology by reviewing and interpreting technical test results and data

7 3 4

PC10. use sophisticated technology to monitor and identify faults in the production process

6 3 3

PC11. work closely with cross functional teams from Operations, Tech Operations, CMC, Supply Chain, Analytical, Quality, R&D etc.

6 3 3

PC12. Identification/ verification of CPPs and CQAs and other important parameters.

7 3 4

PC13. verify design space and understand set of input ranges (CPPs) that provide high probability that CQAs will meet specification

6 3 3

Q


35 | P a g e

PC14. support the control strategy to assure focus on critical points

6 3 3

PC15. assurance of clear documentation of all process/product knowledge

6 3 3

PC16. work with the integrated interdisciplinary team of experts: Operations, Tech Operations, CMC, Supply Chain, Analytical, Quality, R&D etc.

6 3 3

Total 80 48 52

LFS/N0513 (Carry out

reporting and documentation

for research activities)

PC1. develop research objectives and proposals for own or joint research

100

8 4 4

PC2. translate knowledge of advances in the subject area into research activity

8 4 4

PC3. assist in the preparation of proposals and applications to external bodies, e.g. for funding and contractual purposes

7 3 4

PC4. conduct individual and collaborative research projects

6 3 3

PC5. write up research work for presentation and publication

7 3 4

PC6. record details accurately in appropriate format in adherence with confidentiality and intellectual property rights (IPR) guidelines of organization

6 3 3

PC7.continually update knowledge and understanding in field or specialism

7 3 4

Q


36 | P a g e

PC8.manage own research and administrative activities, with guidance if required

8 4 4

PC9.validating the research information at regular cycles

6 3 3

PC10.provide updates and status reports to senior management on a regular basis; report on performance against plan

7 3 4

PC11.interpret the research results correctly

6 3 3

PC12.ensure that the final document meets regulatory and compliance requirements

8 4 4

PC13.make sure documents are available to all appropriate authorities to inspect

8 4 4

PC14.make presentations

8 4 4

Total 100 48 52

LFS/N0514 (Assist in

planning and communicating

research activities)

PC.1 assist in planning the use of research resources, laboratories and workshops as appropriate

100

12 6 6

PC2. assist in planning and managing own research activity in collaboration with others

12 6 6

PC3. contribute to the planning of research projects

13 6 7

PC4. prepare papers for steering groups and other bodies

12 6 6

PC5.communicate material of a specialist or highly technical nature to principal investigator

12 6 6

Q


37 | P a g e

PC6.contribute to the production of research reports and publications

13 6 7

PC7.deal with routine communication using a range of media

13 6 7

PC8.present information on research progress and outcomes to bodies supervising research, e.g. steering groups

13 6 7

Total 100 48 52

LFS/N0515 (Undertake initiative,

problem solving and decision-

making)

PC1. use new research techniques and methods in adherence to the organizational SOPs

100

14 7 7

PC2. use initiative and creativity to identify areas for research, develop new research methods and extend the research portfolio

14 7 7

PC3. use creativity to analyze and interpret research data and draw conclusions on the outcomes

14 7 7

PC4.deal with problems which may affect the achievement of research objectives

14 7 7

PC5.analyze and interpret the results of own research and generate original ideas

14 7 7

PC6.contribute to decisions affecting the work of the team

15 7 8

PC7.contribute to collaborative decision making with colleagues

15 7 8

Total 100 49 51

LFS/N0101 (Maintain a

healthy, safe and

PC1.observe and comply with your company’s current health, safety

100 10 5 5

Q


38 | P a g e

secure working environment in the life sciences

facility)

and security policies and procedures

PC2.while carrying out work, use appropriate safety gears like head gear, masks, gloves and other accessories as mentioned in the guidelines

10 5 5

PC3.report any identified breaches in health, safety, and security policies and procedures to the designated person

10 5 5

PC4.responsible for maintaining discipline at the shop-floor area

10 5 5

PC5.identify and correct any hazards that individual can deal with safely, competently and within the limits of their authority

10 5 5

PC6.adhere and comply to storage and handling guidelines for hazardous material

10 5 5

PC7.identify and recommend opportunities for improving health, safety, and security to the designated person

10 5 5

PC8.complete any health, safety and security records legibly and accurately

10 4 6

PC9.report any hazards that you are not competent to deal with to the relevant person in line with organizational procedures and warn other people who may be affected

10 4 6

PC10.follow your company’s emergency

10 5 5

Q


39 | P a g e

procedures promptly, calmly, and efficiently

Total 100 48 52

LFS/N0104

(Coordinate with manager and

team members for research

activities)

PC1. understand the work output requirements

100

12 6 6

PC2. comply with company policy and rule

12 6 6

PC3. proactively inform supervisor on issues requiring intervention

12 6 6

PC4. deliver quality work on time and report any anticipated reasons for delays

13 6 7

PC5. put team over individual goals

12 6 6

PC6. be able to resolve conflicts

13 6 7

PC7. learn how to multi-task relevant activities

13 6 7

PC8. impart training to team members/cross-function team members

13 6 7

Total 100 48 52

eye on it qualifications pack - occupational … · 2018-01-10 · kb5. scale-up and post-approval...

Documents