Piramal Pharma Solutions is the Contract Development and Manufacturing arm of Piramal Pharma Ltd., with operations across North America, Europe and Asia. We are a global leader in integrated solutions and offer a unique platform of services across the drug lifecycle – from drug discovery and development to commercial manufacturing of drug substances and drug products. Our capability as an integrated service provider & experience with various technologies enable us to serve innovator and generic companies worldwide.
- Department: Quality Assurance
- Posts: QA Officer – Quality Assurance
- Qualification: A college / university qualification in a scientific subject
- Experience: 02 to 03 yrs
- Location: Grangemouth, Scotland
- 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.