Associate MQA Downstream

Roles & Responsibilities
• Act as the primary Quality Assurance contact on the manufacturing floor for Terminal Sterilization, Visual Inspection, and Packaging operations
• Ensure strict compliance with cGMP, GxP, and Pfizer quality standards across downstream manufacturing activities
• Review and approve electronic Batch Records (eBR), batch reports, and assess deviations, alarms, and AMP exceptions with guidance from senior QA members
• Perform batch start-up and end activities including sensor challenge tests, recipe verification, and documentation checks
• Conduct Acceptable Quality Level (AQL) sampling, inspections, and review equipment audit trails
• Perform routine process checks, daily walkthroughs, and promptly report non-compliance or quality observations
• Assess equipment breakdowns and alarms for potential impact on product quality and patient safety
• Review alarm trends and participate in quarterly evaluations
• Support investigations, troubleshooting activities, and continuous improvement initiatives to minimize downtime and improve process efficiency

Qualifications
• M.Pharm or M.Sc (Life Sciences or related discipline)

Experience
• More than 1 year of experience in Manufacturing Quality Assurance, Quality Assurance, or Production within a pharmaceutical manufacturing environment

Skills
• Strong understanding of cGMP and pharmaceutical quality systems
• Hands-on experience with batch record review, inspections, and manufacturing floor QA activities
• Ability to collaborate effectively with cross-functional manufacturing, engineering, and quality teams
• Good problem-solving and troubleshooting skills in regulated environments
• Excellent written and verbal communication skills

About the Organization
Pfizer is a global pharmaceutical leader driven by science, innovation, and a strong commitment to quality and patient safety. With a culture rooted in compliance, collaboration, and continuous improvement, Pfizer offers professionals the opportunity to make a meaningful impact on global healthcare through high-quality manufacturing and quality assurance excellence.