Senior Validation Expert

5 days ago

Lucknow, Uttar Pradesh, India beBeeValidation Full time ₹ 15,00,000 - ₹ 20,00,000

We are seeking a highly skilled Validation Specialist.

Job Description

The ideal candidate will have expertise in sterile injectable manufacturing processes and aseptic techniques.

  • 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.
  • Prepare and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with 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 and suitability for product changeover.
  • Prepare, review, and approve process validation protocols, data, and reports to confirm process robustness and consistency in product quality.
Key Requirements
  • Expertise in validation methodologies and regulatory guidelines.
  • In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • Strong analytical and problem-solving skills.
  • Effective communication and documentation skills.
  • Ability to manage cross-functional teams and prioritize tasks.

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