A Quality Assurance Professional

2 weeks ago

Amrāvati, Maharashtra, India beBeeQualification Full time ₹ 30,00,000 - ₹ 40,00,000
Job Title:

Quality Assurance Specialist

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  • ">
  • • Prepare, review and approve validation protocols and reports for media fill studies, ensuring aseptic process integrity.">
  • • Analyze remote media fill results, identify deficiencies and recommend corrective or preventive actions.">
  • • Prepare and review area qualification protocols and reports for classified manufacturing areas based on environmental monitoring and qualification data from the site.">
  • • Prepare and review periodic requalification protocols, data and environmental monitoring summaries for compliance with cGMP and regulatory requirements.">
  • • Prepare, review and approve Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols and reports for manufacturing equipment.">
  • • Support and participate in Factory Acceptance Test (FAT) execution for equipment at vendor locations.">
  • • Prepare and review utility qualification documentation including HVAC, Water for Injection (WFI) and compressed air system validation.">
  • • Prepare, review and approve cleaning validation protocols and reports to ensure adequacy, compliance and suitability for product changeover.">
  • • Prepare, review and approve process validation protocols, data and reports to confirm process robustness and consistency in product quality.">
  • • Maintain and update the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and site needs.
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