Quality Assurance Specialist

4 days ago

Grangemouth, Falkirk, United Kingdom Piramal Pharma Solutions Full time
Job Description

Piramal Pharma Solutions is a leading developer and manufacturer of high-quality biological reagents, seeking a Quality Assurance Officer to join their growing team in our QA department.

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 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 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 potential issues to the QA manager.
  • Support and lead 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.

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