Interim QP

£0.00 - £850 per day
  1. Permanent
  2. Good Manufacturing Practice (GMP)
Hertfordshire
Posting date: 28 Feb 2019
QA.TG.21914_1551369420

ProClinical is advertising a vacancy for an Interim Qualified Person position with an unparalleled biotechnology company. This exciting organisation, provides business consultation and related services to companies in the cell therapy and regenerative medicine industries, is seeking a driven and personable applicant to join their team in Hertfordshire.

The Qualified Person (QP) will translate strategic direction into a Quality framework that defines, directs, and governs the tactical application of GMP compliance for the Manufacturing Centre. This will predominantly focus 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"). They 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 Responsibilities:

  • Directly reporting to the Head of QA with close interaction with the Manufacturing Centre Management Team
  • Providing subject matter expertise in quality assurance, aseptic manufacturing, and environmental microbiology to Manufacturing Centre staff and Collaborators
  • Ideally acting as Site Microbiologist; otherwise providing expert advice on Annex 1 requirements by approving the facility environmental monitoring, gowning, and cleaning regimes.
  • Providing expert advice for microbiology changes and deviations and coaching QC staff on microbiology as required (note: line management of the microbiology laboratories is not a part of this job specification).
  • Ensuring the QMS is fit for purpose for a multi-purpose, multi-client facility, and maintain processes to ensure site compliance to the QMS.
  • Maintaining processes for batch certification for Collaborators and performing batch certification of ATMPs and/or ATIMPs for Collaborators.
  • Performing QP approval of Manufacturing Centre data (e.g. environmental monitoring data) to support certification by Collaborator QPs, Product Quality Reviews, etc.
  • Developing and maintaining QP to QP Agreements, as required, with Collaborator QPs.
  • Representing the Manufacturing Centre as a QP to external regulators, inspectors, and Collaborators.
  • Preparing and managing regulatory agency and client inspections, including co-hosting as required.

Skills and Requirements:

  • An education to Degree level in a life sciences discipline.
  • Extensive knowledge of EU/MHRA and FDA regulatory environments.
  • Significant experience in sterile manufacturing, ideally cellular and/or gene therapies; otherwise experience in biologics will be considered.
  • Experience acting as a Site Microbiologist; otherwise demonstrable expertise in environmental monitoring, cleaning and gowning requirements for EU Grade A, B, C, and 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 with an IRCA certification.
  • Experience of analytical methods associated with cell and gene therapies ideally.
  • Experience of analytical requirements for regulatory submissions and analytical tech transfer
  • Fluency in English, in both a written and verbal capacity.
  • Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solving problems.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.

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 contact Tom Green at +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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