Executive - Quality Assurance - IPQA - Injectable

2 - 5 years

2 - 4 Lacs

Posted:3 weeks ago| Platform: Naukri logo

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Skills Required

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

  • Ensure cGMP and GDP practices are followed in the respective facility work areas.
  • Review Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
  • Conduct in-process checks and line clearance at various batch manufacturing stages (Manufacturing, Filtration, Filling, Sealing).
  • Review executed batch records for completeness and accuracy.
  • Collect samples at different stages of batch manufacturing, including in-process and finished product sampling.
  • Ensure shop floor compliance by reviewing equipment usage logbooks.
  • Oversee validation activities such as Aseptic Process Simulation (Media Fill) and Process Validation.
  • Review Risk Assessments for equipment, instruments, and processes.
  • Evaluate calibration reports for accuracy and compliance.
  • Assess Preventive Maintenance and Breakdown reports.
  • Analyze audit trails and alarm reports related to equipment and systems.
  • Perform other assignments delegated by the Reporting Manager or Head of Department, aligned with qualification, experience, and training.

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Alembic Pharmaceuticals

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