Qualified Person (Hybrid)
RK23521
Contract – 6 months
Meath



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Meath. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.





Duties:

• Bring energy, knowledge, innovation, and leadership to carry out the following:
• Perform Qualified Person (QP) duties in certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures.
• Assure batch manufacturing and testing has been performed in accordance with cGMP and the relevant marketing authorization (MA) or clinical trial authorization, product specification file, legal obligations and/or technical agreement. Manage and/or escalate any potential CGMP and/or other concerns in a timely manner.
• Provide oversight of deviations (including approval of significant deviations) and laboratory investigations related to drug substance manufacture, testing and those that may present potential effect on product and /or material.
• Confirm change requests with product impact which require expanded review (e.g., regulatory, stability, testing impact) have been appropriately reviewed, approved and technically closed.

• BSc. degree (or higher) in Biotechnology, Chemistry, Biology or in a relevant discipline.
• EU QP Qualification
• 5years experience of certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures.
• Expert level of knowledge of relevant GMPs, regulations and current industry trends.