Mqa Upstream Associate

3 hours ago

Visakhapatnam Andhra Pradesh, India Pfizer Full time

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.

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