Lead Compliance Specialist

1 day ago


Dholka, Gujarat, India beBeeCompliance Full time ₹ 80,00,000 - ₹ 1,25,00,000
Job Description

The role of Assistant Manager involves ensuring compliance with Good Manufacturing Practices (GMP) guidelines and regulatory expectations. Key responsibilities include reviewing and releasing batches of API, conducting quality assurance checks, and coordinating stability sampling.

Broadly speaking, the job requires reviewing batches of Active Pharmaceutical Ingredients, performing quality control measures, and planning manufacturing activities to ensure compliance with GMP standards.

  • Reviewing and releasing API batches, including intermediate stages of production
  • Conducting in-process quality assurance checks
  • Coordinating area clearance for scheduled manufacturing activities
  • Ensuring day-to-day compliance for manufacturing facilities during batch manufacturing activity
  • Reviewing BMR related ROA for Release of Drug Substance (Bulks)
  • Managing Cell Banks, including issuance, trending monitoring, and reconciliation
  • Coordinating CAPA plans/risk mitigation plans, QA Oversight GLP, and Self Inspection Plans
  • Preparing Annual Product Quality Review (APQR) reports for all products manufactured at the facility
  • Identifying training needs and implementing a training index
  • Reviewing and verifying GMP/GLP checks in QC and Manufacturing areas of the Biotech division

Additional tasks may be assigned by the immediate supervisor or HOD from time to time.



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