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 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 Quality Assurance and Control