Qualified Person (Onsite)
RK23517
Contract – 11 months
Tipperary



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. 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:

• 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 manufactur1ed 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.

• 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
• 2 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 recognised 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 and acknowledgement from the EU competent authority where the pharmacy degree was completed to meet the educational requirements of Article 49 of EU Directive 2001/83/EC and Article 97 of the EU Regulation 2019/6.