Validation Expert

3 days ago

Rajkot, Gujarat, India beBeeSterilization Full time ₹ 30,00,000 - ₹ 40,00,000

Quality Assurance Specialist

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We are seeking an experienced Quality Assurance Specialist with a strong background in sterile injectable manufacturing processes and aseptic techniques. The ideal candidate will have expertise in validation methodologies, regulatory guidelines, analytical skills, problem-solving abilities, effective communication skills, and documentation proficiency.

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Key Responsibilities:

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  • Prepare, 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 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, ensuring test protocols are followed and results are documented.">
  • 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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Requirements:

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  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.">
  • 10-15 years of experience in the field of sterile injectable manufacturing processes and aseptic techniques.">
  • Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.).">
  • Strong analytical and problem-solving skills.">
  • Effective communication and documentation skills.">
  • Ability to manage cross-functional teams and prioritize tasks.">
  • Proficiency in QMS tools and software.">
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