Validation Manager- Injectable

Role & responsibilities

Strategic & Leadership:

• Lead the QA Validation function for sterile injectables manufacturing facility.
  
• Develop, implement, and periodically review the

  Validation Master Plan (VMP)

  .
• Provide strategic direction for validation activities in line with corporate and regulatory requirements.
  
• Mentor, train, and supervise the validation team.
  

Validation & Qualification:

• Oversee qualification of

  facility, cleanrooms, HVAC, water systems, equipment, utilities, and computerized systems

  .
• Manage

  process validation, cleaning validation, aseptic process validation (media fills), and hold-time studies

  for injectables.
• Ensure timely revalidation and continuous verification activities as per defined schedule.
  
• Review and approve validation protocols, risk assessments, and reports.
  

Regulatory Compliance:

• Ensure adherence to

  cGMP, EU Annex 1, USFDA, MHRA, WHO, and ICH guidelines

  in all validation activities.
• Evaluate impact of

  change controls

  on validation requirements and ensure proper implementation.
• Lead and support investigations, deviations, CAPA, and ensure timely closure.
  

Audit & Inspection Readiness:

• Act as SME (Subject Matter Expert) for validation during

  regulatory and customer audits

  .
• Address and close validation-related audit observations and regulatory queries.
  
• Maintain robust documentation practices ensuring

  data integrity and traceability

  .

Cross-functional Collaboration:

• Work closely with

  Production, QC, Engineering, R&D, and Regulatory Affairs

  to ensure smooth execution of validation activities.
• Provide technical input for technology transfers, new product introductions, and facility expansions.
  

Continuous Improvement:

• Drive improvements in validation systems, adopting

  risk-based approaches

  and latest validation trends.
• Implement digital/automated solutions to strengthen compliance and efficiency.
  
• Promote culture of quality, compliance, and operational excellence.
  

Preferred candidate profile