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 adaptable and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
Role Summary for Associate Manager:
The MQA Downstream Associate Manager is responsible for primary contact of quality on the floor, Particularly in the Terminal sterilization, Visual Inspection and Packing areas of production and monitor processes for compliance to cGMP standards.
Responsible for ensuring operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging operations.
Responsibilities:
MES quality 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.
Experience:
B. Pharm, M. Pharm, MSc.
6-8 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility.