Senior Executive - Quality Assurance

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