Sterile Manufacturing Quality Assurance Specialist

23 hours ago

Coimbatore, Tamil Nadu, India beBeeQuality Full time ₹ 30,00,000 - ₹ 40,00,000
Quality Assurance Specialist Role

We are seeking a highly experienced Quality Assurance Specialist to join our team in Coimbatore, India.

Job Responsibilities:
  • Validation Activities:
  • Prepare, review, and approve validation protocols and reports for media fill studies, ensuring aseptic process integrity.
  • Conduct remote media fill results analysis, identify deficiencies, and recommend corrective or preventive actions.
  • Develop and review area qualification protocols and reports for classified manufacturing areas (Grade A–D) based on environmental monitoring and qualification data from the site.
  • Generate 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 (onsite when required, otherwise through live remote connection), ensuring test protocols are followed and results are documented.
  • Develop 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.
  • Develop, 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.
Required Skills and Qualifications:
  • Expertise in sterile injectable manufacturing processes and aseptic techniques.
  • In-depth knowledge of 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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