eye on it qualifications pack - occupational …lsssdc.in/pdf/190410112837.pdf · kb10. knowledge...

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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

New Delhi E-mail:

Qualifications Pack-Research Associate- Product

Development/ Synthesis/ Medicinal Chemistry SECTOR: LIFE SCIENCES

SUB-SECTOR: PHARMACEUTICAL AND BIOPHARMACEUTICAL

OCCUPATION: RESEARCH AND DEVELOPMENT

REFERENCE ID: LFS/Q0505

ALIGNED TO: NCO-2004/NIL

Research Associate Product Development, also designated as Research Associate Synthesis/ Medicinal Chemistry is responsible for a wide variety of tasks related to a product development, including pre product development activities, planning and assisting with data collection; data analysis; and writing and disseminating research results.

Brief Job Description: Research Associate Product Development is responsible for assisting in product development, synthesis, medicinal chemistry based research, carrying out research related activities along with its reporting and documentation, problem solving and decision-making, Co-ordinate with manager and team members and maintaining healthy and safe working environment.

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. He/she must understand the importance of compliance with company protocols while carrying out research.

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Introduction

QUALIFICATIONS PACK - OCCUPATIONAL STANDARDS FOR LIFE SCIENCES INDUSTRY

Qualifications Pack For Research Associate Product Development/ Synthesis/ Medicinal Chemistry

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Qualifications Pack Code LFS/Q0505

Job Role Research Associate Product Development/Synthesis/Medicinal

Chemistry

Credits(NSQF) TBD Version number 1.0

Industry Life Sciences Drafted on 15/12/14

Sub-sector

Pharmaceutical and Biopharmaceutical

Last reviewed on 01/08/16

Occupation Research and Development

Next review date 01/08/19

NSQC Clearance on 20/07/2015

Job Role Research Associate Product Development/Synthesis/Medicinal Chemistry

Role Description

Responsible for assisting in product development, carrying out research related activities along with its reporting and documentation, problem solving and decision-making, Co-ordinate with manager and team members and maintaining healthy and safe working environment.

NSQF level Minimum Educational Qualifications Maximum Educational Qualifications

5

Masters in relevant Science discipline (Preferably Organic Chemistry)/ 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/N0516: Assist in product development

2 LFS/N0513: Carry out reporting and documentation for

research activities

3 LFS/N0514: Assist in planning and communicating

research activities

4 LFS/N0515: Undertake initiative, problem solving and

decision-making


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

working environment in the life sciences facility

6 LFS/N0104: Coordinate with Supervisor and team

members

Optional N.A.

Performance Criteria As described in the relevant NOS units

Job

Det

ails


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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


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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 Procedures (s)

NPD New Product Development

Acr

on

yms

v LFS/N0516 : Assist in product development

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National Occupational

Standard

Overview

This Occupational Standard describes the knowledge, understanding and skills required for a Research Associate Product Development to assist in product development.


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Unit Code LFS/N0516

Unit Title (Task)

Assist in product development

Description This NOS unit is about the Research Associate Product Development assisting in product development

Scope

This unit / task covers the following:

Pre product development activities

Activities to be carried out during product development

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

Element


Pre product development activities

To be competent, the user/individual on the job must be able to: PC1. support in developing exploratory development proposals for new innovation

products

PC2. support in carrying out technical feasibility analysis on the NPD ideas by

analyzing current development plans, new scientific developments and

competitive activities

PC3. conduct stability studies, generate stability data & prepare stability reports for

innovation products

Activities to be carried out during product development

PC4. supporting in execution of product (innovation) development related activities PC5 support execution of allocated product development responsibilities PC6 . identify issues on projects PC7. assist in resolution of issues supported by good data analysis

Knowledge and Understanding (K)

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

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 KA5. knowledge of competitor products KA6. 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. importance of compliance with company protocols while carrying out research KB2. chromatographic scanners, vial handling systems, agitators KB3. knowledge of GLP and GMP KB4. knowledge of SOPs KB5. product life cycle knowledge and understanding KB6. knowledge of product properties

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KB7. knowledge of manufacturing process KB8. technical reasons for manufacturing defects KB9. knowledge of medicinal chemistry concepts and technologies, various synthesis

technologies, and analytical and purification techniques KB10. knowledge of software like Chemdraw, ISIS, Scifinder etc

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

Reading Skills

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 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. attention to detail


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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

NA


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NOS Version Control

NOS Code LFS/N0516



Industry Sub-sector Pharmaceutical and Biopharmaceutical


Occupation R&D Next review date 01/08/19

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

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Overview

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


Standard


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Unit Code LFS/N0513

Unit Title (Task)

Carry out reporting and documentation for research activities

Description This NOS is about a Research Associate Product Development carrying out reporting and documentation for research activities

Scope

The unit/task covers the following:

Pre research activities

Activities to be carried out during research process

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

Activities to be carried out during research process

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



The user/individual on the job needs to know and understand: KA1. all relevant Standard Operating Procedures(SOPs) of the company KA2. institutional and professional code of ethics and standards of practice KA3. privacy policy of the company KA4. safety and health policies and regulations for the workplace


The user/individual on the job needs to know and understand: KB1. knowledge on different standard reference material KB2. knowledge of drugs, products, side effects, adverse reactions, process

knowledge

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KB3. statistical analysis of test data

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

Reading Skills

The user/individual on the job needs to know and understand how to: SA3. 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: SA4. interact with people to effectively gather information SA5. listen effectively and orally communicate information accurately SA6. 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 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


SB7. pass on relevant information to other departments SB8. arithmetic and Mechanical Aptitude

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


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Customer Centricity

NA

NOS Version Control

NOS Code LFS/N0513






LFS/N0514 : Assist in planning and communicating research activities

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Overview

This Occupational Standard describes the knowledge, understanding and skills

required of a Research Associate Product Development to plan and

communicate research activities


Standard


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Unit Code LFS/N0514

Unit Title (Task)

Assist in planning and communicating research activities

Description This NOS unit is about a Research Associate Product 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



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

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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. 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

NA


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NOS Version Control

NOS Code LFS/N0514






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

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Overview

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


Standard


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Unit Code LFS/N0515

Unit Title (Task)

Undertake initiative, problem solving and decision-making

Description This NOS unit is about the Research Associate Product Development taking initiation, 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

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. Analyze 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


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

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

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C. Core Skills/ Generic Skills

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

D. Professional Skills

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. attention to detail

Customer Centricity

NA


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NOS Version Control

NOS Code LFS/N0515






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

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Standard

Overview

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


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

Identify and recommend opportunities for improving health, safety, and security 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 carry out: PC1. observe and comply with your 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 area

PC5. identify and correct any hazards that you can deal with safely, competently and

within the limits of your 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 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


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

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

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


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

Decision Making


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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

Customer Centricity

The user/individual on the job needs to know and understand how to: SB3. build and maintain positive and effective relationships with colleagues,

customers and suppliers

Problem Solving

The user/individual on the job needs to know and understand how to: SB4. apply problem solving approaches in different situations

Analytical Thinking


Critical Thinking

The user/individual on the job needs to know and understand how to: SB6. apply balanced judgments to different situations


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NOS Version Control

NOS Code LFS/N0101



Industry Sub-sector Pharmaceuticals and Bio Pharmaceuticals


Occupation Manufacturing, Quality, Supply Chain, R&D

Next review date 01/08/19

LFS/N0104 : Coordinate with Supervisor and team members

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Standard

Overview

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


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Unit Code LFS/N0104

Unit Title (Task)

Coordinate with Supervisor and team members

Description This NOS unit is about a Research Associate Product 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. receive work instructions from reporting manager

PC2. communicate to reporting supervisor about process-flow improvements, quality

defects received from previous process

PC3. communicate any potential hazards or expected process disruptions

PC4. provide requisite information, documents, clarifications to manager during

actual audits

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Coordination with team members

PC5. work as a team with colleagues and share work as per their or own work load

and skills

PC6. support/assign personnel/team members to support internal and external audit

activities as per instructions of superiors/supervisor

PC7. provide documented shift handovers to the next person in the shift

PC8. communicate and discuss work flow related difficulties in order to find solutions

with mutual agreement


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

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

KA1. implications that any non-compliance with health, safety and security may have on individuals and the organization


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. 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: SA5. report/observation writing skills


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Reading Skills

The user/individual on the job needs to know and understand how to: SA6. read notes/comments from the supervisor SA7. 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

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

Analytical Thinking

NA

Plan and Organize

NA

Customer Centricity

NA


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NOS Version Control

NOS Code LFS/N0104



Industry Sub-sector Pharmaceuticals and Bio Pharmaceuticals


Occupation Quality, R&D Next review date 01/08/19

Qualifications Pack For

Research Associate Product Development/ Synthesis/ Medicinal Chemistry

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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

Qualifications Pack For

Research Associate Product Development/ Synthesis/ Medicinal Chemistry

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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

Qualification Pack for Research Associate Product Development/ Synthesis/ Medicinal Chemistry

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CRITERIA FOR ASSESSMENT OF TRAINEES

Job Role Research Associate Product Development/ Synthesis/ Medicinal Chemistry Qualification Pack LFS/Q0505 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 Marks Obtained (600)

Out of Theory Practical

LFS/N0516 (Assist in product

development)

PC1. support in developing exploratory development proposals for new innovation products

100

14 7 7

PC2. support in carrying out technical feasibility analysis on the NPD ideas by analyzing current development plans, new scientific developments and competitive activities

14 7 7

PC3. conduct stability studies, generate stability data & prepare stability reports for innovation products

14 7 7

PC4. supporting in execution of product (innovation) development related activities

15 7 8

PC5. support execution of allocated product development responsibilities

14 7 7

PC6. identify issues on projects 14 7 7

PC7. assist in resolution of issues supported by good data analysis

15 7 8

Q


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Total 100 49 51

LFS/N0513 (Carry out

reporting and documentation

for research activities)

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

100

7 3 4

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

7 3 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

7 3 4

PC5. write up research work for presentation and publication

7 3 4

PC6. record details accurately in appropriate format

7 3 4

PC7.continually update knowledge and understanding in field or specialism

7 3 4

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

7 3 4

PC9.validating the research information at regular cycles

7 3 4

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

8 4 4

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

7 3 4

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

8 4 4

PC14.make presentations 7 3 4

Total 100 44 56

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

13 6 7

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

12 6 6

Q


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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

PC6.contribute to the production of research reports and publications

13 6 7

PC7.deal with routine communication using a range of media

12 6 6

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

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

15 7 8

PC6.contribute to decisions affecting the work of the team

14 7 7

PC7.contribute to collaborative decision making with colleagues

15 7 8

Total 100 49 51

LFS/N0101 (Maintain a

healthy, safe and secure

working environment in

PC1.observe and comply with your company’s current health, safety and security policies and procedures 100

10 5 5

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

10 5 5

Q


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the life sciences facility )

accessories as mentioned in the guidelines

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 you can deal with safely, competently and within the limits of your 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 procedures promptly, calmly, and efficiently

10 5 5

Total 100 48 52

LFS/N0104 (Coordinate

with supervisor and team members)

PC1.receive work instructions from reporting manager

100

12 6 6

PC2.communicate to reporting supervisor about process-flow improvements, quality defects received from previous process

13 6 7

PC3.communicate any potential hazards or expected process disruptions

12 6 6

PC4.provide requisite information, documents, clarifications to manager during actual audit

13 6 7

Q


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PC5.work as a team with colleagues and share work as per their or own work load and skills

12 6 6

PC6.support/assign personnel/team members to support internal and external audit activities as per instructions of superiors/supervisor

12 6 6

PC7.provide documented shift handovers to the next person in the shift

13 6 7

PC8.communicate and discuss work flow related difficulties in order to find solutions with mutual agreement

13 6 7

Total 100 48 52

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