LSC have a great contract opportunity for Qualified Person to join a leading biotech company based in County Meath.
Job Purpose
This role will be part of our Quality Assurance Team in our state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland.
What you will do:
- 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.
Education and Experience:
- 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.
- Expert level of knowledge of relevant GMPs, regulations and current industry trends. Communication, decision making, people influencing and project management skills.
- Problem-solving / critical thinking - ability to understand connections between different technical/quality system areas and recognize potential compliance issues.
- BSc. degree (or higher) in Biotechnology, Chemistry, Biology or in a relevant discipline.
For our contracting opportunities in the pharmaceutical sector in Ireland, candidates must possess either a Stamp 1G or a Stamp 4 visa. We regret that we are unable to provide visa sponsorship currently. Thank you for your understanding.
Apply via this advert or contact Siobhan Cummins at +353214777329 if you have any more questions about this opportunity!
