Senior Executive

6 days ago


Pune, Maharashtra, India Shalina Healthcare Full time ₹ 12,00,000 - ₹ 24,00,000 per year

Role & responsibilities:

Key Responsibilities

  • Monitor raw material dispensing activities as and when required.
  • Perform Batch Shipper Record (BSR) and shipper inspections as per SOP.
  • Issue, review, and reconcile controlled formats across departments.
  • Prepare master Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR).
  • Issue BMR/BPR to Production for batch processing as per approved requisition.
  • Prepare, review, approve, issue, and retrieve SOPs and formats as per defined procedures.
  • Draft new SOPs and coordinate their implementation.
  • Ensure execution of training programs and documentation as per the training planner.
  • Prepare and maintain the competency matrix for QA and related personnel.
  • Conduct risk assessment, mitigation, and periodic reviews.
  • Manage rejection and destruction activities for the Jejuri site.
  • Perform daily IPQA checks and monitoring as per defined frequencies in SOPs.
  • Handle validation functions in absence of validation personnel.
  • Oversee upkeep, review, and destruction of control samples.
  • Perform container inspections and related product evaluations as per SOP.
  • Conduct self-inspections and ensure readiness for internal/external audits.
  • Ensure GMP compliance, sanitation, and hygiene across departments.
  • Review completed BMRs/BPRs, compile batch documentation, and ensure readiness for batch dispatch.
  • Execute ERP-related transactions for IPQA activities.
  • Carry out QMS-related activities assigned by the HOD.
  • Lead and manage the IPQA team (E3 level) and allocate responsibilities accordingly.

Qualifications & Experience

  • Education: B. Pharm / M. Pharm / B. Sc / M. Sc in relevant discipline
  • Experience: 6 -8 years of experience in IPQA or QA function in a regulated pharmaceutical manufacturing environment


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