Associate Manager - MQA

Responsibilities

• Ensure cGMP compliance within Terminal Sterilization, Visual Inspection, and Packaging operations
• Maintain regulatory compliance in accordance with established cGMP practices and Pfizer standards
• Review electronic Batch Records (eBR), batch reports, and equipment audit trails
• Perform Acceptable Quality Level (AQL) sampling, inspections, and record results in batch records
• Conduct batch start-up and end activities, including sensor challenge tests and recipe reviews
• Perform daily walkthroughs and random process checks to report observations to the Senior Team Leader
• Assess equipment breakdowns regarding product quality and patient safety
• Review equipment alarms and monitor quarterly alarm trends
• Identify process gaps and participate in procedure simplification to increase efficiency
• Support handling regulatory, corporate, and internal audits/inspections

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

Preferred Qualifications

• Experience with quality administered systems
• Strong organizational skills and high attention to detail
• Proven experience with regulatory compliance and documentation
• Ability to mentor and review the work of colleagues

About the Company

Pfizer is a global leader in the pharmaceutical industry, dedicated to discovering and developing innovative therapies that transform millions of lives. We foster a culture of individual ownership and are looking for talented professionals to join our mission of making the world a healthier place.