Validation Manager- Injectable

2 days ago

Baddi, Himachal Pradesh, India Venus Remedies (VRL) Full time ₹ 12,00,000 - ₹ 36,00,000 per year

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.

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