Associate MQA Downstream

Responsibilities

• Serve as the primary quality contact on the production floor for Terminal Sterilization, Visual Inspection, and Packing areas
• Ensure operating state of cGMP compliance and maintain regulatory compliance in accordance with practices
• Review electronic Batch Records (eBR), batch reports, and equipment audit trails
• Perform Acceptable Quality Level (AQL) sampling, inspection in VIDT, and batch record review and release
• Conduct batch start-up and end activities, including sensor challenge tests and recipe reviews
• Perform random process checks and daily walkthroughs to report observations
• Assess equipment breakdowns regarding product quality and patient safety
• Review equipment alarms and assess quarterly alarm trends
• Identify process gaps to assist in procedure simplification, reducing downtime and increasing efficiency

Requirements

• M. Pharma or M.Sc. degree
• 1+ years of experience in Manufacturing Quality Assurance, Quality Assurance, or Production within a pharmaceutical manufacturing facility
• Sound knowledge of current Good Manufacturing Practices (cGMP/GxP)
• Experience with pharmaceutical industry quality administered systems
• Effective written and oral communication skills
• Ability to work effectively in both individual and interdepartmental team environments

About the Company

Pfizer is a global leader in the pharmaceutical industry, dedicated to delivering safe and effective products to patients through a culture of science and risk-based compliance. We strive to unearth innovative therapies that transform millions of lives and make the world a healthier place.