Sterile Product Assurance Professional

2 days ago

Amrāvati, Maharashtra, India beBeeQuality Full time ₹ 20,00,000 - ₹ 25,00,000
Senior Quality Assurance Specialist

We are seeking a highly experienced Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the quality and integrity of sterile injectable products.

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.
  • Area Qualification Protocols:
    • 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.
  • Installation, Operational, and Performance Qualifications:
    • Prepare, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.
  • Utility Qualification Documentation:
    • Prepare and review utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
  • Cleaning and Process Validations:
    • 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.
  • Validation Master Plan (VMP):
    • Maintain and update the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and site needs.
Requirements:
  • 10-15 years of experience in quality assurance and sterile injectable manufacturing.
  • 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.
  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.

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