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Qualified Person
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Proclinical is seeking a Qualified person to be based in Hertford on a permanent basis. This role will be based at a pharmaceutical company, whose aim is to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies.
The Qualified Person (QP) will participate in the translation of strategic direction into a Quality framework that defines, directs and governs the tactical application of GMP compliance for the Manufacturing Centre. In the first instance, this will be predominantly focused on developing and supporting the delivery of a fit for purpose Quality Management System and providing practical quality subject matter expertise to both CGT and collaborating residents ("Collaborators"). This activity will be required to support the initial grant of the facility MIA and MIA(IMP), and then to support on-going operations.
The Manufacturing Centre hosts Collaborator manufacturing activities. The QP will perform batch certification for Collaborator manufacturing activities, as required, and act as a QP for the Manufacturing Centre.
Reporting to the Head of Quality Assurance, this role will ensure that the new Manufacturing Centre meets the standards and expectations of the regulatory authorities and Collaborators.
Job Responsibilties:
- Direct report to the Head of QA with close interaction with the Manufacturing Centre Management Team
- Provide subject matter expertise in quality assurance, aseptic manufacturing and environmental microbiology to Manufacturing Centre staff and Collaborators
- Ideally, act as Site Microbiologist, otherwise provide expert advice on Annex 1 requirements by approving the facility environmental monitoring, gowning and cleaning regimes. Provide expert advice for microbiology changes and deviations and coach QC staff on microbiology as required (note: line management of the microbiology laboratories is not a part of this job specification)
- Ensure the QMS is fit for purpose for a multipurpose, multi-client facility, and maintain processes to ensure site compliance to the QMS
- Maintain processes for batch certification for Collaborators and perform batch certification of ATMPs and or ATIMPs for Collaborators
- Perform QP approval of Manufacturing Centre data (e.g. environmental monitoring data) to support certification by Collaborator QPs, Product Quality Reviews etc.
- Develop and maintain QP to QP Agreements, as required, with Collaborator QPs
- Represent the Manufacturing Centre as a QP, to external regulators, inspectors and Collaborators
- Participate in the preparation and management of regulatory agency and client inspections, including co-hosting as required.
Skills and Requirements:
- Extensive knowledge of EU/MHRA and FDA regulatory environments
- Significant experience in sterile manufacturing, ideally cellular and/or gene therapies, otherwise biologics
- Ideally, experience acting as Site Microbiologist, otherwise demonstrable expertise in environmental monitoring, cleaning and gowning requirements for EU Grade A, B, C, D manufacturing environments
- Experience in interacting with regulatory authorities
- Experience in interacting with clients and collaborators
- Track record of continuous improvement
- Experience in supplier auditing, ideally IRCA certified auditor
- Experience of analytical methods associated with cell and gene therapies ideally, experience of analytical requirements for regulatory submissions and analytical tech transfer
- Motivated, pragmatic and practical to support the mission of the company to accelerate the development of a commercial cell-based therapy industry in the UK
- Able to evaluate complex situations and find solutions for them in a professional manner
- Excellent interpersonal, written and verbal communication skills
- Having current and up to date professional knowledge, expertise and best practice
- Proven ability to engage constructively with colleagues at all levels across different departments
- Eligible to act as a Qualified Person under Directive 2001/83/EC
- Educated to Degree level in a life sciences discipline
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Tom Green on +44 203 814 1317 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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