We are currently sourcing a Qualified Person (QP) to join our high performing quality team. In this role, you will:
- Release of Finished and Semi-Finished Products
- To meet Internal & External cGMP Requirements
- By assisting in the completion of Annual Product Review (data collection, graphic analysis…)
- By participating to the review and updating of the regulatory filing (US & European, DMF type 1…), with the collaboration of the regulatory department.
- By completing quality assurance review of batch documentation as required:
- By making sure that critical deviations are investigated and resolved
- Set up a performance indicator
- Decide efficiently what is to be done with products
- By ensuring the follow-up of the necessary corrective actions implemented in consequence of a quality failure
- By reviewing and assessment of GMP critical systems
- Participating and follow-up the audits and/or inspections carried out at the site by the authorities or clients, propose corrective actions and check that they are applied.
- Participate in technical and scientific meetings, in training days, trade fairs, conferences… (technological intelligence…). Provide to operations all guidelines and documents.
- Keep up-to-date with the Regulation Evolution
- Contribute to the Quality Assurance Plan Realisation
Education & Experience:
- Education to meet the requirements for position of Qualified Person as defined in EU GMP volume 4 and annex 16.
- Experience to requirements for position of Qualified Person as defined in EU GMP volume 4 and annex 16
- Relevant 3rd honours degree with 3 yrs practicing QP experience preferred
- 2 yrs QA industrial experience in pharma
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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