Quality Assurance - QMS ( Injectable Plant)

Key Responsibilities:

1. QMS Implementation & Oversight:

• Maintain and continually improve QMS elements such as deviation handling, change control, CAPA, OOS/OOT, risk assessments, and quality reviews.
  
• Ensure compliance with GMP, GAMP, ISO, ICH (Q9, Q10), and regulatory agency requirements (e.g., USFDA, MHRA, WHO, EU GMP).
  

2. Deviation & CAPA Management:

• Investigate deviations in manufacturing, QC, and support areas.
  
• Perform root cause analysis (RCA) and drive timely and effective CAPA implementation.
  
• Monitor the closure timelines and effectiveness verification of CAPAs.
  

3. Change Control & Document Control:

• Evaluate and manage changes in equipment, facility, process, and documents.
  
• Review and manage controlled documents including SOPs, protocols, risk assessments, etc.
  
• Ensure document lifecycle management in compliance with GDP.
  

4. Audit Readiness & Regulatory Compliance:

• Support internal audits, regulatory inspections, and third-party audits.
  
• Prepare and maintain audit documentation, observation responses, and compliance tracking.
  
• Coordinate self-inspections and site quality risk assessments.
  

5. Training & Quality Culture:

• Conduct GMP training programs related to QMS and quality culture.
  
• Monitor training compliance across functions and maintain training matrices.
  

6. APQR/PQR & Quality Metrics:

• Participate in the preparation of Annual Product Quality Reviews (APQRs).
  
• Compile, monitor, and report Quality KPIs and metrics to management.
  

7. Sterile Manufacturing Support:

• Ensure QMS processes support sterility assurance practices.
  
• Review and ensure compliance for media fill protocols, aseptic area controls, and environmental monitoring deviations.