Senior Quality Assurance Specialist

3 days ago

India beBeeValidation Full time ₹ 15,00,000 - ₹ 20,00,000
Quality Assurance Specialist Job Description

We are seeking a Quality Assurance Specialist to join our team at a leading healthcare provider. The ideal candidate will have in-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.

Key Responsibilities:

  • Analyze and prepare validation protocols, reports, and data for media fill studies, equipment qualification, and cleaning validation.
  • Review and approve periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements.
  • Maintain and update the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and site needs.

Key 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.

Education and Qualifications:

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

The successful candidate will have 10-15 years of experience in quality assurance and a strong understanding of regulatory requirements. A B1/B2 USA visa is preferred but not required.

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