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Sterile Injectables Validation Expert

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Kollam, Kerala, India beBeeQuality Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Title:

Quality Assurance Specialist - Sterile Injectables

Overview

Medivant Healthcare is seeking an experienced Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in sterile injectable manufacturing processes and aseptic techniques.

Responsibilities
  • Develop, review, and approve validation protocols and reports for media fill studies to ensure 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.
  • Develop and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements.
  • Develop, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.
  • Support Factory Acceptance Test (FAT) execution for equipment at vendor locations.
  • Develop and review utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
  • Develop, review, and approve cleaning validation protocols and reports to ensure adequacy, compliance, and suitability for product changeover.
  • Develop, review, and approve process validation protocols, data, and reports to confirm process robustness and consistency in product quality.
Requirements
  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
  • 10-15 years of experience in Quality Assurance.