Quality Validation Officer

£0.00 - £32000.00 per annum
  1. Permanent
  2. Validation
  3. United Kingdom
Banbury, Oxfordshire
Posting date: 26 Apr 2019
QA.LP.22977_1556273395

An internationally leading contact logistics specialist is seeking for a Quality Validation Engineer to join their team in the UK. Based in Oxfordshire, this position is an exciting opportunity to work with a company that provides sector expertise, global scale, and local knowledge to design and manage supply chains to an excellent standard.

Job Responsibilities:

  • Delivery of all the points mentioned in the purpose of the role, focusing on the delivery of the Quality Agenda and Strategies, particularly focusing on Validation.
  • Overseeing Patient Safety - SISPQ (Safety, Integrity, Strength, Purity & Quality) of products.
  • Developing and maintaining the validation lifecycle process for all systems/ equipment as per GxP requirements.
  • Providing support to mitigate the risk of non-compliance (GMP/GDP/ISO/H&S) across the areas of responsibilities and across the wider business.
  • Providing support to eliminate non-compliance findings during regulatory and clients inspections.
  • Maintaining professional knowledge of relevant and current regulatory requirements within the EU and UK in relation to validation.
  • Working in collaboration with other operational and functional teams to ensure delivery of company strategy & Quality agenda and to maximise efficiencies for best practice.
  • Supporting Quality activities associated with clients.
  • Other tasks as instructed by the Quality Validation Manager and VP QA RCR UKI
  • Preparing, executing, and reporting validation documentation in line with site procedures and regulatory requirements.
  • Validating/ qualifying relevant equipment, systems, and processes in compliance with GMP/GDP/GAMP requirements. This includes product storage, vehicles, temperature monitoring equipment, Secondary operations, and computer systems.
  • Ensuring validation activities are conducted in a timely manner and in compliance with GxP and project milestones.
  • Supporting and participating on local project management and implementation.
  • Ensuring the validation and calibration status is maintained
  • Supporting and advising on Process Improvements being driven to deliver compliance and efficiency within their sites/areas of responsibilities.
  • Supporting the Change Control, Quality Report & CAPA's processes and ensure completed in a timely manner.
  • Supporting where required audit processes such as Internal Audits & External Audits (regulatory bodies, clients and suppliers).
  • Supporting and guiding departments to ensure full compliance of relevant QMS elements in those areas (inc. CAPA Management, Internal audits, Change Control, Training, SOP approvals, Doc. Control, etc.) .
  • Supporting the quality agenda during clients Monthly and/or Quarterly Business Reviews (MBRs, QBRS) as required.
  • Deputising for Quality Validation Manager when necessary.
  • Other Tasks as instructed by the Quality Validation Manager & VP QA RCR UKI.

Skills and Requirements:

  • Diploma/Degree in Life Science related subject (i.e. Chemistry, Biology, Pharmacology), or at least 3 years experience in QA management within the pharmaceutical/medical devices industry.
  • Diploma/Certificate in Quality
  • Minimum 3 years of experience in QA/QC within the pharmaceutical/Medical Devices Industry.
  • Proven track record in Validation within in a GMP/ GDP/ GxP environment.
  • Fully conversant with GAMP validation requirements.
  • Fully conversant with EU/ UK/ FDA GMP/GDP Regulations and ISO 9001 requirements.
  • Member of Professional bodies related to Quality or the pharmaceutical industry (IRCA, CQI, RPS, RSC, etc.)
  • Experience with regulatory and clients audits.
  • Experience with reviewing/approving Quality/Technical Agreements.
  • Management of Quality Systems in compliance with GxP.
  • Fluency in English, with proficiency in any other language desired.
  • 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 with computer skills, such as MS Office.

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 Leoca Powell at +44 203 854 2624 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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#Compliance/Quality

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