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Pharma Quality Assurance Specialist
2 months ago
The Quality Assurance Technician will play a crucial role in ensuring the quality of our pharmaceutical products. This includes assisting the QA officer in reviewing procedures, batch paperwork, and manufacturing and analytical documentation. The successful candidate will be the QA representative for new campaigns, dealing with aspects such as process instruction sheets, change control, deviation, validation, customer audits, raw material and final product disposition.
Key Responsibilities:- Provide QA input to project activities, including review and approval of change requests, specifications, Standard Operating Procedures, Manufacturing Procedures, and Analytical Procedures.
- Participate in quality-related investigations, assist in the development and approval of effective CAPA to resolve production, audit, and customer issues.
- Identify and escalate any identified cGMP areas of concern.
- Participate in validation activities, including approval of protocols and reports for analytical methods, manufacturing processes, analytical/production/packaging equipment, and cleaning procedures.
- Participate in the audits of suppliers, production, and support functions as required.
- Be involved in the preparation for MHRA/FDA and other regulatory body audits.
- Review relevant documentation relating to incoming raw materials and perform disposition activities as required.
- Review manufacturing, laboratory, and associated documentation prior to performing the relevant disposition of final products. Where potential issues exist, these are to be highlighted to the QA manager.
- Act as the QA representative for the introduction of new products, being a key member of the multi-functional team including R&D, QC, and manufacturing, ensuring that all cGMP documents are appropriate and all cGMP requirements are satisfied.