This is a 6 month contract with our client in Dunboyne.

An exciting opportunity has arisen for an experienced Qualified Person to join our Quality department at our Biologics facility.

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.

EU QP Qualification and experience (at least 5 years) 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.
BSc. degree (or higher) in Biotechnology, Chemistry, Biology or in a relevant discipline.
Expert level of knowledge of relevant GMPs, regulations and current industry trends.
Communication, decision making, people influencing and project management skills.