Pharmaceutical Quality Assurance Role

3 days ago


Thāne, Maharashtra, India beBeeQuality Full time ₹ 60,00,000 - ₹ 80,00,000
Job Title: Quality Assurance Specialist

Job Description:The Quality Assurance Specialist will be responsible for ensuring the quality of pharmaceutical products.

Key Responsibilities:
  1. Review and prepare master documents, including technical documents such as technology transfer, MPCR, BPCR, specification, and standard test procedure, stability data.
  2. Prepare training schedules and provide training on QA-related topics, guidelines, regulatory, and cGMP requirements to all concerned employees.
  3. Prepare and review drug master files and handle regulatory queries.
  4. Evaluate the quality and stability of finished APIs.
  5. Organize and execute internal audit programs, review observations, follow-ups, and closures.
  6. Investigate out-of-specification cases.
  7. Review MSDS and approve.
  8. Prepare annual product quality reviews.
  9. Provide effective CAPA procedures, track completion, and implementation.
  10. Perform validation activities as per validation master plans.
  11. Investigate customer complaints and respond to customers regarding complaints.


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