MQA Downstream Associate Manager

Responsibilities

• Serve as the primary quality contact on the production floor, specifically overseeing Terminal Sterilization, Visual Inspection, and Packing areas.
• Monitor processes to ensure strict compliance with cGMP standards and Pfizer manufacturing policies.
• Manage MES quality operations and maintain regulatory compliance.
• Review electronic Batch Records (eBR), batch reports, and equipment audit trails.
• Perform Acceptable Quality Level (AQL) sampling, inspections, and record results in batch records.
• Execute batch start-up and end activities, including sensor challenge tests and recipe reviews.
• Conduct daily walkthroughs, random process checks, and report observations to the Senior Team Leader.
• Assess equipment breakdowns and alarms regarding product quality and patient safety.

Requirements

• B. Pharm, M. Pharm, or MSc degree.
• 6-8 years of experience in Manufacturing Quality Assurance, Quality Assurance, or Production within a pharmaceutical manufacturing facility.
• Proven experience in reviewing eBR and assessing manufacturing exceptions.
• Ability to work in shifts.

About the Company

Pfizer is a global leader in the pharmaceutical industry, dedicated to delivering safe and effective products to patients worldwide. Our science-driven and risk-based quality culture focuses on innovation and putting the patient first to transform millions of lives through healthcare excellence.