23521-Qualified Person-Meath Contractor

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

Purpose

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

Responsibilities

• 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.

Qualifications

• 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.