Job Description

Current 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.

Required Knowledge, Skills, and Abilities