Associate - Quality Assurance
1 day ago
Qualification: B.Pharm/M.pharm, M.Sc(Microbiology/Chemistry)
1. 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.
Identify gaps and involve in process and procedure simplification, thereby reduce downtime and increase the efficiency.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control
LI-PFE
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