MQA upstream Associate na Pfizer

Key Responsibilities:

Terminal Sterilization Block Operations (Solution/Emulsion Preparation, Vial/Ampoule Washing, Depyrogenation, Filling, Capping, and Collection)

• Ensure compliance with current Good Manufacturing Practices (cGMP) across all sterilization block operations

• Maintain regulatory standards and documentation in alignment with cGMP requirements

• Adhere to Pfizer manufacturing policies and procedures

• Review Electronic Batch Records (eBR) and assess AMPS (Agile Manufacturing Production System) exceptions with supervisor support

• Audit batch reports and equipment trails for accuracy and compliance

• Conduct alarm impact assessments and approve trend reports

• Monitor start-up and in-process activities for adherence to batch records and SOPs

• Ensure manufacturing practices align with approved standards and procedures

• Perform CCTV monitoring to oversee manufacturing process areas

• Conduct daily walkthroughs per cleanroom behavior/coaching protocols and report observations for resolution

• Review daily NVPC (Non-Viable Particle Count) workflows and approve trend reports

• Escalate any non-compliance issues to the supervisor

• Identify process gaps and contribute to simplification initiatives to reduce downtime and improve efficiency

AMPS Responsibilities:

• Review and approve Master Recipes

• Review and approve Master Workflow

• Review and approve Master Data (Graphs, Classes, Entities)

Must-Have Qualifications & Expertise

• Education: B. Pharma / M.Sc. in a relevant discipline

• Experience: 2–5 years in pharmaceutical manufacturing, specifically in Quality Assurance or Production

• Strong knowledge of solution preparation processes

• Familiarity with filling and capping equipment

• Proven experience in reviewing batch records and NVPC trend reports

• Hands-on expertise in manufacturing activities within sterile environments

Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.