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Quality Assurance Specialist
2 months ago
Piramal Pharma Solutions is seeking a highly skilled Quality Assurance Officer to join our team in Grangemouth.
Job SummaryThe Quality Assurance Officer will be responsible for ensuring the accuracy and compliance of procedures, quality management system records, manufacturing batch records, and associated testing. This role will act as the Quality Assurance representative for campaign projects and will be responsible for reviewing and approving process instructions, change controls, deviations, investigations, validation, customer audits/quality requests, and material and product disposition.
Key Responsibilities- Collaborate with internal and external stakeholders to ensure the 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 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.
- Participate in the audits of suppliers and self-inspection of internal production and support functions as required.
- 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.
- 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.
The ideal candidate will have a strong understanding of GMP/GxP regulations and experience in a quality assurance role. They will be able to work independently and as part of a team, with excellent communication and problem-solving skills.
Piramal Pharma Solutions offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
