Arcadis DPS Engineering are a seeking a Clinical Supplies Qualified Person (QP) for a Pharmaceutical assignment located in Ballydine, Tipperary. This is an 11-month contract.
Responsibilities:
* Review and certify batches intended for use in clinical trials to ensure compliance with EU GMP, the Product Specification File, and the Clinical Trial Application.
* Oversee batch certification for products manufactured globally and imported into the EU, including small molecules, biologics, vaccines, and gene therapies.
* Participate in Health Authority inspections and audits to maintain site licences and ensure compliance.
* Manage ongoing compliance activities related to clinical trials, including technical and quality agreements with collaborators.
* Coordinate with cross-functional teams to ensure clinical trial supplies meet quality and regulatory standards.
* Provide expertise on EU regulations, including EudraLex Chapter 4, Annex 13, Annex 16, and EU CTR regulations 536/2014.
* Act as a key contact for quality-related issues, ensuring timely resolution and adherence to standards.
* Support the implementation of process improvements to enhance compliance and efficiency in clinical trial supply management.
Requirements:
* Eligibility to be named as a Qualified Person (QP), with a commitment to maintaining CPD.
* Practical experience with product disposition, including sterile, non-sterile, biologics, vaccines, or gene therapy, and at least two years in quality assurance or qualitative analysis.
* Recognised pharmacy degree or equivalent
* Extensive experience in a cGMP environment, preferably within a Quality function for clinical trials or IMPs.
* Strong organizational and communication skills, with a proactive approach to working on global teams and collaborating with internal and external stakeholders.
DPS is a leading Project Management and Engineering Company delivering Full Service Engineering with a ‘client first’ mentality and personal touch across a range of market sectors: Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up. We have one goal: to deliver more than our clients expect first time, every time.
We’ve been serving industry around the world for 40 years plus, relied on for our agility, original thinking, sound judgement and high-calibre people. What sets us apart is the rapport we build with our clients and the care we take to gain a fundamental understanding of our client’s businesses. We employ over 2800+ people out of our sixteen office locations and we serve a broad range of clients ranging from multinational companies to small generic producers.
DPS Engineering is an Equal Opportunities Employer.
Recruitment Agencies: Please do not reply to this job advert.
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