Quality Assurance Specialist

1 week ago


Bharatpur, Rajasthan, India beBeeCompliance Full time ₹ 30,00,000 - ₹ 50,00,000
Quality Assurance Specialist - Validation and Compliance

We are seeking an experienced Quality Assurance Specialist to join our team. This key role will ensure the quality and integrity of our sterile injectable products.

  • Key Responsibilities:
  • Validate manufacturing processes and equipment to guarantee compliance with regulatory requirements.
  • Analyze results from media fill studies, identify areas for improvement, and recommend corrective actions.
  • Prepare and review area qualification protocols and reports for classified manufacturing areas based on environmental monitoring and qualification data.
  • Support Factory Acceptance Test (FAT) execution for equipment at vendor locations, ensuring test protocols are followed and results are documented.
Required Skills and Qualifications
  • Essential Qualifications:
  • A deep understanding 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.
Benefits

This role offers opportunities for professional growth and development within our organization.



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