sunil resume 1.2.16

Application for suitable post in Manufacturing / Technical Services in pharma industry Sunil I. Sawant Shivanjali Nivas, Near Shraddha hospital, Shrikrishanagar Pimple Gurav Pune 411061 (Maharashtra)Contact: +919890279806; Email: [email protected]

OBJECTIVE:A post graduate in Pharmaceutics (M. Pharm) and master in business administration (MBA operations) Seeking a challenging, rewarding & responsible position in Production / Technical services in reputed Pharmaceutical Organization, which recognizes my true potential & effectively utilizes/nurtures my excellent analytical & technical skills.

SUMMARY OF SKILLS: Conceptually strong in the field of Pharmaceutical Formulation Technology/

Tech transfer/ Quality assurance methods. Conceptually strong with an innovative and analytical & systematic approach to

the work with an eye for detail. Enriched with the ability to learn new concepts & technology within a short span of time.

Result oriented professional with a matured approach with managerial exposure and able to make an effective contribution to the performance of a team with good leadership and motivating capabilities.

An effective team player with exceptional planning and execution skills coupled with a systematic approach and quick adaptability.

EXPERIENCE: 18+ years of experience in manufacturing of Pharmaceutical

formulation in various dosage forms like Tablets, Capsules as well as liquid Orals.

Leading manufacturing team which includes commercial manufacturing/pilot scale product manufacturing/ Technology transfer and documentation team.

Experience in transfer of products for regulated and ROW markets from R&D as well as contract manufacturers. Monitoring the activities of scale up, scale down, process optimisation, process evaluation and validation.

EDUCATIONAL CREDENTIALS: 1. Bachelor of Pharmacy

First class ( 71.23 % ) from Shivaji University2. Master in pharmacy (Pharmaceutics) from Pune University

First class (65.4%) from Pune university3. Master in Business Administration (MBA Operations) from IIBM Pune.

First class (A grade)

mailto:[email protected]


CURRENT ASSIGNMENT:Currently working with Cipla Ltd. Indore since from July.2015 as Head of Department in Solid Oral manufacturing facility. (Unit-IV)

COMPANY PROFILE:

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. For 80 years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 150 countries. Our portfolio includes over 1500 products across wide range of therapeutic categories with one quality standard globally.

Whilst delivering a long-term sustainable business, Cipla recognises its duty to provide affordable medicines. Cipla’s emphasis on access for patients was recognised globally for the pioneering role played in HIV/AIDS treatment as the first pharmaceutical company to provide a triple combination anti-retroviral (ARV) in Africa at less than a dollar a day and thereby treating many millions of patients since 2001. Cipla's mission is to be a leading global healthcare company which uses technology and innovation to meet every day needs of all patients.

This unit state of art manufacturing facility approved by regulatory agencies like US FDA, UK MHRA, MCA South Africa, TGA Australia, WHO Geneva etc., and most of the time appreciated by the auditors.

CURRENT RESPONSIBILITIES:Operation, Control and Monitoring:

Responsible for the selection and design of equipment, plant layout, materials handling, and production planning (production scheduling and ordering of material).

To make monthly plan and co-ordinate with production planning department. Ensure proper planning and execution of the batches in accordance with the plan.

Approval and monitoring of suppliers of materials. To prepare and approve the instructions relating to production

operations i.e. Master Batch Manufacturing Record, Work Orders, SOP’s including the in process controls and to ensure their strict implementation.

To handle and investigate all deviations/OOS/Complaints/ OOT observed as per standard procedure.



To ensure appropriate validation, qualification and calibration of equipment’s are done as per schedule and records are maintained.

Improvement, continuous review and up gradation of existing production SOPs and work systems and to ensure their strict implementation.

Co-ordination with other units / machine manufacturer - supplier / other sections and departments.

To co-ordinate in technology transfer activities.

Quality Management System: Identifying all potential failures wrt equipment, facilities, manufacturing

process, packing, system and personnel including pertinent assumptions, identifying the potential for risk.

Carrying out complaint, OOS/OOT, Deviation /incident and batch failure investigation also carry out investigation and evaluation of rejection generated during processing.

Identifying root cause and propose CAPA and checking the reason for non-conformance, impact on batches/products/items/system, root cause analysis (if applicable) and remedial action.

Identification risk assessment wrt process, equipment’s and facilities and Preparation of action plan in case of higher RPN and risk communication.

Assessing the adequacy of existing control measures, identification and implementation of additional or new control measures as appropriate. Specifying timelines, deliverables and appropriate level of decision making for the risk management process and performing periodic risk assessment.



Ensuring that the change control procedure followed for all the changes is as specified in the change control procedure and evaluating the impact of change.

Checking statutory requirements and other requirements prior to transfer of product.

Review the information provided by sender unit and gap analysis and execution of the product transfer as per the protocol.

Assessment of impact of manufacturing new product on existing facility and evaluation of the risk involved.

Ensure the compliance of any deficiencies raised during self-inspection audits, corporate audits, external audits and regulated and non-regulated audits.

To participate in the implementation and monitoring of quality system and quality policy.

To conduct periodic review of process performance, quality system and submission of review report to senior management.

To ensure timely and effective communication to senior management. Follow up and implementation of suggestion or corrective actions suggested by senior management, continual improvement of the quality system.

Performing Process Validation/Revalidation and Cleaning Validation in co-ordination with quality assurance

To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality.

Good Manufacturing Practices: To monitor compliance with the requirements of cGMP of country where

product is being exported and investigation of factors this may affect product quality.



To ensure that the production records are reviewed and signed by a designated person before they are made available to the Quality Assurance Department.

To ensure on line documentation and timely entries of all operations / activities.

To check the maintenance of the department, premises and equipment’s.

To ensure that all materials are stored under the appropriate conditions as per specification and in an orderly fashion to permit batch segregation and stock rotation.

Responsible for up gradation of existing equipment’s for complying the equipment’s 21 CFR compliance. Printout provision to be made available by installing SCADA systems or upgrading the software.

Safety: Strict adherence to safety, health and environment.

Training: Ensuring the adherence to data integrity by all the employees in the

manufacturing department. Training related to Data integrity to be provided to all departmental employees. Any violation wrt data integrity shall be escalated to the higher management and appropriate corrective actions to be initiated.

Identification of training needs and competency matrix and evaluation of training.

Impart training with respect to Initial (Induction), On the job training, schedule training, GMP, Safety, Hygiene, application and principles of production for department personnel according to the need.

Rendering factory induction to new entrants, verifying the on job training evaluation & training certificate and evaluation of training program for new entrants (contract /temporary worker).



Implementation of Jaagruti initiative for productivity enhancement, capability building, Cost reduction, work simplification, idea generation etc.

Administrative: Responsible and carry out the Department budget wrt Capex and Opex

items required for current financial year and monitoring and maintaining the same throughout the year.

Responsible for recruitment, retention, supervision and motivation of personnel.

Any other work assigned by Unit Head / Factory Management, Stock control and cost control.

PREVIOUS EXPERIENCE:

1. I had 9 years of vast professional experience from reputed organization OMNI PROTECH DRUGS LIMITED BHOSARI PUNE from 1997 to 2006. Following responsibilities handled, Handling of Shop floor activities related to capsule and tablet and liquid

orals. And involved in qualification activities as well. Actively participated in ISO activities and awarded for major contribution.

Worked as core SAP team member for production functions.

2. I had 1.5 years of professional experience from reputed organization ERICA-NIRAMAYA ETHICALS PRIVATE LIMITED JEJURI PUNE from 2006 TO 2007. Following responsibilities handled, Planning and monitoring of production activities related to capsule and

tablet manufacturing and packing. Responsible for qualification of plant and equipment’s.

Involved in tech transfer, validation, qualification and formulation development activities.

3. I had 8.0 years of professional experience from reputed organization Emcure Pharmaceuticals limited Hinjawadi, PUNE from June 2007 TO July 2015, This



plant is approved by regulatory agencies like US FDA, UK MHRA, MCA south Africa, WHO Geneva. Following responsibilities handled.

Responsible for manufacturing activities in General Block and immunosuppressant Block. Responsible for capacity utilization of the facility by using optimum resources.

Handling of projects for creation of general tablet and immunosuppressant facility. Involved in selection of machine required for manufacturing. Responsible for Qualification of facility and equipment’s. Responsible for technology transfer of products from R&D and Contract giver.



KEY SKILLS AND WORKING EXPERIENCE:

1. Working as a production head and successfully handling of production team by producing highest output with no major market complaint and zero batch rejections.

2. Efficient diagnostics of departmental facilities for compliance readiness - No critical & major observations in the area.

3. Effective inventory management at all in process stages for consistent supply to the internal customers. Ensure capacity utilisation for existing commercial products and upcoming ANDA products.

4. Ensuring effective team work – Cross functional working for effective resolution of issues

5. Adherence to the manufacturing budget maintained the opex and capex budget within the financial year. Monthly tracking of the budget and operating expenses of the department.

6. Well aware with the regulatory audits like USFDA, UKMHRA, WHO-Geneva, ANVISA Brazil. Hands on experience for facing these audits.

7. Experience in Tablet, capsule and Liquid oral Department and FDA Maharashtra approval for Capsule and Liquid Oral dosage form.

8. Conceptually strong in the field of Pharmaceutical Formulation Technology9. Experience and worked with production planning and control dept.

ACHIEVEMENTS:1. Manufacturing productivity and network optimization e.g. Batch Size

Optimization, Formula Harmonization. 2. Support cost optimization – Energy efficiency, OEE improvements (For

bottleneck machines: Avg. NLT 60%) & Cycle time reduction.3. Efficient diagnostics of departmental facilities for compliance readiness - No

critical & major observations in the area. Highest output with no major market complaint and zero batch rejection.



4. Maintained high standard on quality and safety - Zero loss time incidents and Improvement in near miss reporting

5. Achieve departmental OTIF > 85% and manpower retention up to 95%. 6. Sustained Yield enhancement and process improvements and simplification

in Formulations.7. FDA Maharashtra approval in Capsule and Liquid Orals section.8. Completed training on SAP and worked with SAP system for Production

functions

COMPUTER SKILL:1. Well aware with MS-office software fluently using all functions related with

office software’s like Excel, Word, PowerPoint etc. 2. Well aware with SAP system and worked with execution level.

PERSONAL INFORMATION: Date of Birth : 06th May 1976 Nationality : Indian Language Proficiency : English, Hindi & Marathi. Sex : Male Marital status : Married

Thanking You,

Mr. Sunil Ishwar Sawant


sunil resume 1.2.16

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