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Pfizer Limited was listed on the Indian stock exchange in 1966. Today, the company has over one lac shareholders in India. With annual sales of over Rs. 2,000 crores, it is the fourth largest multinational pharmaceutical company in India. The Company has a portfolio of over 150 products across 15 therapeutic areas. Its top brands include Prevenar 13, Lyrica, Corex – DX, Dolonex, Enbrel, Becosules, Gelusil and Folvite among others. In addition to its commercial operations, Pfizer Limited also operates a state-of-the-art, award-winning manufacturing facility in Goa that produces more than a billion tablets annually.
Job Description
- Department: Quality Assurance
- Role: Associate
- Qualification: B.Pharm / M.Pharm, M.Sc (Microbiology / Chemistry)
- Job Location: Vizag
Roles & Responsibilities
Responsible for ensuring operating state of cGMP compliance in solution/emulsion preparation, vial/ampoule washing, depyrogenation, filling and capping operations.
2. Maintain regulatory compliance in accordance with cGMP practices.
3. Ensure manufacturing policies and procedures conform to Pfizer standards.
4. Knowledge and hands on experience in reviewing eBR and assessing the impact of AMPs exceptions with technical support/inputs from Sr. Specialist or Supervisor.
5. Review of batch reports and equipment audit trails.
6. Perform EMS alarm impact assessments and monthly trend reports.
7. Ensure start-up and in-process activities performed as per batch record and SOP compliance.
8. Monitor the manufacturing practices and ensure compliance with respect to standards and approved procedures.
9. Perform daily walk throughs and report observations to the supervisors.
10. Perform equipment breakdown assessments w.r.t to product quality and patient safety with technical support/inputs from Sr. Specialist or Supervisor.
11. Review and approval of equipment alarms and review of alarm trends.
12. Report any non-compliance to the supervisor.
13. Should have trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values.
14. Identify gaps and involve in process and procedure simplification, thereby reduce downtime and increase the efficiency.
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