Manufacturing - AMgr/Mgr

Location

Aurangabad | India

Job description

Principal Responsibilities

To work so as to ensure the highest professional standards in all aspects of Product Manufacturing and Development in accordance with the Company's key objectives, its philosophy and values. To ensure company's business interests are served and kept paramount at all times by manufacturing goods in the right quantity and cost, while maintaining the stringent quality standards set by the company, thereby maintaining and enhancing its good image.

Production

1. Coordinating with purchase department for timely receipt of all excipients and packing materials as per monthly production plan.
2. Coordinating with MFG. site for planning of monthly manufacturing schedule.
3. Checking of compliance of GOOD MANUFACTURING PRACTICES during the manufacturing of Servier products.
4. Checking of compliance of STANDARD OPERATING PROCEDURES during the manufacturing of Servier products.
5. Checking of compliance of in process control parameters during manufacturing stage of each batch.
6. Preparation and review of MFR/MPR/BMR/BPR/validation protocols and reports etc.
7.  To keep control on Batch yield, RM/PM material consumption, Dispatch of goods on time etc.
8. Work on Export project manufacturing.

Quality Assurance

1. Checking for compliance of SERVIER specifications for all active principles, excipients and packaging materials.
2. Checking for compliance of SERVIER specifications for all in process samples and finished products.
3. Monitoring and release each of the finished product batch.
4. Handling of market complaints
5. Monitoring Analytical trend of finished products.
6. Review of RM/PM Specifications and Method of analysis.
7. Monitoring of solvent consumption/WS/Impurity consumption
8. Carry out internal audits and preparations of audit reports.
9. Preparation of product transfer protocols and reports etc
10. Quality Agreement review
11. Annual product review
12. Responsible for management of QMS, investigations
13. Responsible for compliance with technical or regulatory requirements related to the quality of finished products and the approval of the release of the finished product for sale etc.
14. EXPORT project full documentation and implementation of new requirements in place.

Quality Control

1. Checking all the analytical reports of RM/PM/FG
2. Auditing mfg. site Labs for GLP along with public testing labs
3. Checking the routine analysis results of our products at Public testing labs
4. Checking the stability study results of our products at Public testing labs
5. Track on solvent consumption/ HPLC column /WS/Impurity consumption.
6. Handling Analytical method development and method transfer activities at respective manufacturing sites etc.
7. Preparation of analytical study agreements.
8. Maintaining Stability planner.
9. Method validation, stability study, Excipient incompatibility study, stress etc protocol design.

New Products

1. Assistance in execution of the scale up and commercial batch formula for new products.
2. Assisting in the preparation of dossiers for new products etc.

Other Activities

1. Carrying out annual technical vendor audits.
2. Coordination between all vendors.
3. Design and review of the artworks , change part drawings for new products.

Profile Requirements

Minimum Requirements

1. A graduate degree in Pharmacy.
2. At least Eight years Post Qualification experience, progression and achievement in a medium to large multinational pharmaceutical organisation in Production, Quality Control and Quality assurance.
3. Experience of regulated market.
4. Knowledge of Dossier preparation and respective data generation.

Personal Qualities

1. Ability to behave decisively.
2. Ability to grasp complex concepts easily.
3. Attention to minute detail.
4. Excellent planning, negotiating, and organizing skills.
5. Ability to motivate co-workers, colleagues and others.
6. Patience and self confidence.
7. Ability to operate in a systematic and logical manner.
8. Good judgment.
9. Ability to prioritize
10. Strong analytical skills.

Job tags

Salary