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Assistant Manager - Quality Assurance, Pharma

Assistant Manager - Quality Assurance, Pharma

ConfidentialAnkleshwar, India
7 days ago
Job description

Job Title : Sr. Executive / Assistant Manager – Quality Assurance, Pharma

Educational Qualification

  • B. Pharm / M. Pharm from a reputed university

Experience

  • 8 to 10 years of similar experience in a regulatory-approved OSD manufacturing large unit.
  • Job Responsibilities & Accountabilities

    We are looking for an experienced QA professional to join our team and lead Deviation & Complaint Investigations, along with core QMS activities.

    Key Responsibilities

  • Lead deviation and market complaint investigations, with timely CAPA execution
  • Ensure effective implementation and tracking of CAPAs from deviations & complaints
  • Review Batch Manufacturing & Packing Records, APQR, and SOPs
  • Manage Change Controls, Validations / Qualifications, and QMS documentation
  • Conduct regulatory gap assessments and support compliance plan execution
  • Coordinate GMP training, documentation control, and audit readiness
  • What We're Looking For

  • 8–10 years of QA experience in pharmaceutical manufacturing (formulations)
  • Strong understanding of cGMP, investigation tools, and regulatory expectations (USFDA, MHRA)
  • Skilled in QMS systems.
  • Excellent documentation, analytical, and coordination skills
  • Skills Required

    Sops, MHRA, Validations, Usfda

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    Quality Assurance Manager • Ankleshwar, India