QA Officer – API

6 days ago


Nandesari Ind Estate Vadodara Gujarat, India Easy HR Solution Full time ₹ 4,20,000 per year

Job Summary:

The QA Officer will be responsible for implementing and maintaining quality systems to ensure compliance with GMP and regulatory requirements. The role includes reviewing documents, monitoring in-process activities, managing deviations, and supporting audits in the API manufacturing facility.

Key Responsibilities:

  • Review and approve Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and related quality documents.
  • Ensure all manufacturing, packing, and laboratory activities comply with GMP standards.
  • Handle and document deviations, change controls, CAPA, and OOS/OOT investigations.
  • Review and control of SOPs, specifications, and master documents.
  • Participate in internal audits, vendor audits, and regulatory inspections.
  • Conduct line clearance for manufacturing and packaging activities.
  • Coordinate with production, QC, and warehouse teams to ensure quality compliance.
  • Support in qualification and validation activities (equipment, process, cleaning).
  • Maintain document control systems and ensure data integrity practices.
  • Provide GMP training and awareness to plant personnel.

Job Types: Full-time, Permanent

Pay: ₹15, ₹35,000.00 per month

Benefits:

  • Health insurance
  • Provident Fund

Work Location: In person


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