Responsibilities:
- 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.
If you're interested, please contact Liam Smith on 01925 909043 or
