
Pharmaceutical Quality Assurance Role
3 days ago
Job Description:The Quality Assurance Specialist will be responsible for ensuring the quality of pharmaceutical products.
Key Responsibilities:
- Review and prepare master documents, including technical documents such as technology transfer, MPCR, BPCR, specification, and standard test procedure, stability data.
- Prepare training schedules and provide training on QA-related topics, guidelines, regulatory, and cGMP requirements to all concerned employees.
- Prepare and review drug master files and handle regulatory queries.
- Evaluate the quality and stability of finished APIs.
- Organize and execute internal audit programs, review observations, follow-ups, and closures.
- Investigate out-of-specification cases.
- Review MSDS and approve.
- Prepare annual product quality reviews.
- Provide effective CAPA procedures, track completion, and implementation.
- Perform validation activities as per validation master plans.
- Investigate customer complaints and respond to customers regarding complaints.
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