Sterile Manufacturing Process Specialist

3 days ago

Jamnagar, Gujarat, India beBeeQuality Full time ₹ 40,00,000 - ₹ 50,00,000

Job Opportunity

We are seeking a Quality Assurance Professional to join our team in Jamnagar, India. The ideal candidate will have a strong background in sterile injectable manufacturing processes and validation methodologies.

The successful candidate will be responsible for:

  • Preparing, reviewing, and approving validation protocols and reports for media fill studies to ensure aseptic process integrity.
  • Analyzing remote media fill results, identifying deficiencies, and recommending corrective or preventive actions.
  • Preparing and reviewing area qualification protocols and reports for classified manufacturing areas based on environmental monitoring and qualification data from the site.
  • Preparing and reviewing periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements.
  • Preparing, reviewing, and approving Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.
  • Supporting and participating in Factory Acceptance Test (FAT) execution for equipment at vendor locations, ensuring test protocols are followed and results are documented.
  • Preparing and reviewing utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
  • Preparing, reviewing, and approving cleaning validation protocols and reports to ensure adequacy, compliance, and suitability for product changeover.
  • Preparing, reviewing, and approving process validation protocols, data, and reports to confirm process robustness and consistency in product quality.
  • Maintaining and updating the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and site needs.

Key Skills and Competencies

  • Deep knowledge of 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.

Education and Qualifications

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

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