Sterile Manufacturing Process Validator

3 days ago


Tiruchi, Tamil Nadu, India beBeeQualityAssurance Full time ₹ 15,00,000 - ₹ 20,00,000

Seeking a Quality Assurance Specialist to ensure the integrity of sterile injectable manufacturing processes.

Your key responsibilities will include:

  • Validation Protocol Management: Prepare, review, and approve validation protocols and reports for media fill studies, area qualification, periodic requalification, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), cleaning validation, and process validation.
  • Data Analysis and Reporting: Analyze remote media fill results, identify deficiencies, and recommend corrective or preventive actions. Prepare and review environmental monitoring summaries and data for compliance with cGMP and regulatory requirements.
  • Documentation and Communication: Maintain and update the Validation Master Plan (VMP) to ensure alignment with regulatory expectations and site needs. Communicate effectively with cross-functional teams and prioritize tasks.

To succeed in this role, you will need:

  • Deep Knowledge: In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • Expertise: Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP, etc.).
  • Analytical Skills: Strong analytical and problem-solving skills.
  • Effective Communication: Effective communication and documentation skills.

Educational Requirements:

  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.


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