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
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