LSC have a great contract opportunity for a Clinical Supplies Qualified Person to support our clients Global Development Quality Team that supports expanding Clinical Trials programs in Europe.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
As QP you will be named on the site license supporting the release of clinical trials supplies and reporting to the Senior Director of Quality Assurance.
What you will do:
- The QP will be involved in the review and certification of batches intended for use in clinical trials, to ensure compliance with EU GMP, the Product Specification File and the Clinical Trial Application.
- This role will encompass product manufactured across the company Global Supply Chain and subsequently imported into the EU. Products include Small Molecules, Large Molecules - Biologics, Vaccines, Gene Therapy etc
- The QP will be involved with Health Authority Inspections to maintain the site licences, audits both internal and external.
- This role will also be involved in ongoing compliance activities related to clinical trials, for example technical and quality agreements with collaborators, stock recovery activities etc.
SKILLS AND QUALIFICATIONS:
In order to excel in this role, you will more than likely have:
- Eligible to be named as a Qualified Person (QP) and to have maintained CPD.
- Practical experience with disposition of product types such as Sterile, Nonsterile, Biologics, Vaccine, Gene Therapy or ATMP, is preferable. Including at least two year's experience in quality assurance or qualitative analysis of related medicinal products. Familiarity with EudraLex Chapter 4, Annex 13, Annex 16 and applicable EU CTR regulations 536/2014.
- A recognized pharmacy degree course at a third level institution in Ireland or if the pharmacy course has been completed outside of Ireland evidence of Pharmaceutical Society of Ireland registration
Please note that 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 +353214777329 if you have any more questions about this opportunity!
