Piramal Pharma is a world-leading developer and manufacturer of high-quality biological reagents and is seeking a Quality Assurance officer to join their growing team in our QA department in Grangemouth.
The Quality Assurance officer will 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.
The QA officer is expected to identify, escalate and work to address any GMP/GxP issues with potential impact to product quality or quality compliance.
Together we offer fantastic opportunities for committed employees to learn and develop their career with us. At Piramal , we research, develop, and supply Biopharma products and services that impact the lives of millions of people each day to make life better, and keep us safer. Your health and well-being matters to us and that’s why we offer you the flexibility to do what’s important to you whether that’s the ability to flex your start and finish times. Where possible, we support a working pattern that suits your lifestyle and helps you reach your ambitions.
Key Roles/Responsibilities
- QA primary point of contact (internal and external) for designated projects.
- 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
- 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.
- Verify manufacturing, laboratory and associated documentation prior to performing the relevant disposition of products. Where potential issues exist, these are to be highlighted to the QA manager.
- Promote and work to ensure compliance with all relevant GMP/GxP requirements.
- 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.Warehouse on call team.