Assistant Manager

2 days ago

Pune, Maharashtra, India Enzene Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Role & responsibilities

Quality Documentation & Compliance:

Handling and preparation of GMP-related documents including Change Controls, Deviations, OOS, CAPA, Lab Incidents, APQR, and Investigations, with diligent follow-up to ensure timely closure.

  • Document Management:

    Management and handling of Cell Bank documentation and Technology Transfer documents to support regulatory and operational compliance.
  • Validation & Review Activities:

    Review of Process Validation and Cleaning Validation protocols and reports, Batch Manufacturing Records (BMR), and Continued Process Verification (CPV) data to ensure accuracy and alignment with regulatory expectations.
  • CPV & PQR Analysis:

    Handling of JMP software for statistical analysis and reporting of CPV and Product Quality Review (PQR) data.
  • Internal Audits & GMP Compliance:

    Execution and monitoring of Internal Audit programs to uphold Good Manufacturing Practices (GMP) and drive continuous quality improvement across the organization.
  • IPQA & Shop Floor Oversight:

    In-process Quality Assurance (IPQA) oversight including shop floor investigations to ensure compliance during manufacturing operations.
  • Team & QA Engagement Management:

    Coordination and management of QA team activities, ensuring effective execution of quality systems and engagement in cross-functional initiatives

Preferred candidate profile

Experience - Between 9 to 12 years

Qualification - M.Sc or M.Pharm

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