Well established Pharmaceutical Manufacturing Company (Tablets and Pain Relief) have a new opportunity for an experienced Quality Assurance Officer in their new state of the art manufacturing facility.
Duties to include:
Quality document review prior to QP release. Generating BPRs for manufacturing. Amending Manufacturing and Packaging master production records. Reviewing & approving BOMs on SAGE. Preparing batch release documentation, C of A and Batch Release Certificate. Handling customer complaints and enquiries, including medical product information, coordinate technical product complaint investigations. Handling and reporting of Adverse Drug Reactions / Adverse Events. Liaising with HPPV (third party Pharmacovigilance). Product Quality Report preparation. Raising and assessing deviations, change controls & CAPAs. Artwork management including liaising with regulatory affairs and third party. Controlled document management (versioning & database management). Authoring and reviewing controlled documents (manufacturing logs, SOPs, etc.). Raising purchase orders for artwork tasks and packaging materials. Internal, external and customer audits.(Co-Auditor) Laboratory systems administration. General IT & administration assistance for all departments. Generating investigation reports. New QA staff training.
Desirable experience to include:
Degree educated Product Quality Report preparation. Internal, external and customer audits.(Co-Auditor). Handling customer complaints and enquiries, including medical product information, coordinate technical product complaint investigations.The role is based in Hertfordshire