Job Title: Quality Assurance Specialist
About the Role
An opportunity has arisen for a Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring that all IOQ documentation generated by C&Q vendors is reviewed and approved. You will also prepare, execute, and summarize reports from PQ stage onwards for a full suite of equipment and instruments required for an aseptic fill finish facility incorporating Filling Line, Lyophilisers, Clean Utilities, Visual Inspection, QC Laboratories, Warehousing.
Responsibilities
Evaluation of validation requirements including areas of new equipment, change controls, new requirements. Monitor status of projects and get updates where required, from a validation perspective. Provide support to ensure that validation status reports are maintained through the issuing of monthly reports and regular validation group meetings. Liaise with project managers to ensure project schedule is adhered to. Assessment of current practices to ensure compliance with cGMP requirements. Review/Implementation of procedures, reports, results etc. for compliance. Review/ Implementation of both global and AICL, CSV documentation. Responsible for the coordination of SDLC Documentation. Review and approval of all projects validation protocols plant wide. Review and approval of project change controls. Provide input into the development of company validation standards.