Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and creative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
- What You Will Achieve
In this role, you will:
- Responsible for ensuring operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging operations.
- Maintain regulatory compliance in accordance with cGMP practices
- Ensure manufacturing policies and procedures conform to Pfizer standards.
- Knowledge and hands on experience in reviewing eBR and assessing the impact of AMPs exceptions with technical support/inputs from Sr. Team leader.
- Review of Batch reports, and Equipment audit trails
- Perform Acceptable Quality level sampling, Inspection and record the results in Batch records for all products.
- Perform batch start-up and end activities viz.
sensor challenge tests, recipe review etc.
- Perform random process checks for Terminal Sterilization, Visual Inspection and Packaging.
- Perform Daily walkthroughs and report observations to the Sr. Team leader.
- Perform Equipment breakdown assessments w.r.t to Product Quality and patient safety with technical support/inputs from Sr. Team Leader.
- Review and assessment of equipment alarms and review of quarterly alarm trends.
- 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. AMPS Recipe review and validation of recipe.
- Experience in handling regulatory, corporate and internal auditors/ inspectors
- Here Is What You Need(Minimum Requirements)
- B. Pharm, M. Pharm, M