MQA upstream Associate

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 :

Must-Have Qualifications & Expertise

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.

Quality Assurance and Control

Skills Required

Filling