Ref. 01294
Qualified Person (QP)
Our client, a leading pharmaceutical company committed to transforming global health through research and innovation, is seeking a Qualified Person (QP) for a contract position within their Global Development Quality Team. This role will support the release of clinical trial supplies as part of their expanding Clinical Trials programs in Europe.
We are looking to recruit a QP to be named on the site licence, responsible for overseeing the release of clinical trial materials.
This is a 12-month contract position reporting to the Senior Director of Quality Assurance.
What you will do:
Bring energy, knowledge, innovation and leadership to carry out the following:
• 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
• 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.
REQUIREMENTS
• Eligible to be named as a Qualified Person (QP) with maintained CPD.
• Extensive cGMP experience ideally within clinical trials/IMP Quality functions.
• A recognised pharmacy degree (Ireland) or PSI registration plus EU recognition under Article 49 of Directive 2001/83/EC and Article 97 of Regulation 2019/6.
• An Academic Qualification at least equivalent to a Level 8 scientific with a recognised postgraduate course meeting EU QP educational requirement.
• Strong understanding of EudraLex Chapter 4, Annexes 13 & 16, and EU CTR Regulation 536/2014.
• Strong organisational and communication skills; ability to work on global teams.
• Hands-on experience with sterile, non-sterile, biologics, vaccines, gene therapy, or ATMPs is preferable with at least 2 years’ experience in Quality Assurance or qualitative analysis of medicinal products.
• Experience conducting audits and hosting inspections.
• Effective verbal and written communication skills in collaborating to colleagues and associates both inside and outside the organisation.
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