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Quality Assurance Specialist
2 months ago
About the Role:
Piramal Pharma Solutions is seeking a highly skilled Quality Assurance Officer to join our team in Grangemouth. As a Quality Assurance Officer, you will play a critical role in ensuring the accuracy and compliance of procedures, quality management system records, manufacturing batch records, and associated testing.
Key Responsibilities:
- Act as the Quality Assurance representative for campaign projects, ensuring accuracy and compliance of procedures, quality management system records, manufacturing batch records, and associated testing.
- Be the QA representative for new products and for change projects, dealing with aspects including review/approval of process instructions, change controls, deviations, investigations, validation, customer audits/quality requests, and material and product disposition.
- Identify, escalate, and work to address any GMP/GxP issues with potential impact to product quality or quality compliance.
- Collaborate with internal and external stakeholders to ensure quality of all product-related activities.
- Provide QA input to project activities including review and approval of change requests, specifications, Standard Operating Procedures, Manufacturing Procedures, Analytical Procedures, and associated documentation.
- Participate in quality-related investigations, assist in the development, approval, and implementation of effective CAPA in order to resolve production, audit, and customer issues.
- Participate in validation activities including approval of protocols and reports for analytical methods, manufacturing processes, analytical/production/packaging equipment, and cleaning procedures.
- Be involved in preparation for and successful completion of MHRA/FDA and other regulatory body audits.
- Coordinate quality disposition activities associated with designated materials and products.
- Highlight any potential issues to the QA manager.
- Support and lead as required, quality process improvements and quality management system improvements within the department and on site.
- Escalate any identified GMP/GxP areas of concern to Quality Management and QP.
About Us:
Piramal Pharma Solutions is a world-leading developer and manufacturer of high-quality biological reagents. We are committed to delivering exceptional quality and service to our customers.
