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QA - Validation & Equipment Qualification

2 weeks ago

Khopoli, Maharashtra, India Kopran Full time ₹ 8,00,000 - ₹ 12,00,000 per year

Role & responsibilities

  • Plan, execute, and review Validation Protocols and Reports (Process, Cleaning, Analytical Method, and Computer System Validation).
  • Execute and review Equipment Qualification activities (IQ/OQ/PQ, Re-qualification).
  • Support preparation and maintenance of Validation Master Plan (VMP).
  • Ensure compliance with cGMP, FDA, MHRA, WHO, and other international regulatory guidelines.
  • Coordinate with cross-functional teams (Production, Engineering, QC, R&D) for smooth execution of validation activities.
  • Conduct risk assessments and gap analysis for equipment, utilities, and processes.
  • Review and maintain SOPs, protocols, and technical documentation related to validation.
  • Handle deviations, CAPA, and change controls related to validation/qualification.
  • Participate in internal and external audits, providing necessary validation and qualification documents.
  • Ensure timely execution of periodic re-validation and re-qualification activities.

Preferred candidate profile

  • Strong knowledge of cGMP, ICH, FDA, and other regulatory guidelines.
  • Hands-on experience in equipment qualification (IQ/OQ/PQ).
  • Good understanding of cleaning validation, process validation, and computerized system validation.
  • Strong documentation and technical writing skills.
  • Excellent analytical, problem-solving, and communication skills.
  • Ability to work collaboratively in cross-functional teams.