Posted:5 hours ago|
Platform:
Work from Office
Full Time
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
Quality Assurance and Control
Pfizer
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