Sterile Product Validation Expert

2 days ago

Anand, Gujarat, India beBeeQualification Full time ₹ 15,30,000 - ₹ 20,40,000

We are seeking an experienced Sterile Product Validation Expert to join our Quality Assurance team.

About the Role

The ideal candidate will have a strong background in sterile injectable manufacturing processes and aseptic techniques. They will be responsible for ensuring the quality and integrity of our products through the development, implementation, and maintenance of validation protocols and reports.

Key Responsibilities
  • Validation Activities:
    • 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 (Grade A–D) 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.
    Requirements
    • A minimum of 10-15 years of experience in sterile injectable manufacturing processes and aseptic techniques.
    • Expertise in validation methodologies and regulatory guidelines.
    • 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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