Work as MQA upstream Associate at Pfizer - B.Pharm, MSc Apply

Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.

Post : MQA upstream Associate

Job Description
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)

Candidate Profile
• 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

Additional Information
Experience : 2–5 years
Qualification : B.Pharma / M.Sc
Location : Vizag
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : 4939043
End Date : 25th October 2025