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MQA upstream Associate en Pfizer

Pfizer · Visakhapatnam, Indien · Onsite

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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

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