Quality Assurance Specialist

2 weeks ago

Ahmedabad, Gujarat, India beBeeQuality Full time ₹ 15,00,000 - ₹ 30,00,000
Job Title: Quality Assurance Specialist

We are seeking a highly skilled professional to join our Quality Assurance team.

The ideal candidate will have extensive experience in sterile injectable manufacturing processes and aseptic techniques.

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 (onsite when required, otherwise through live remote connection), 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.
Required Skills and Competencies:
  • In-depth 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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