QA Validation Officer

£0.00 - £32000.00 per annum
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Distribution Practice (GDP)
  3. United Kingdom
Banbury, Oxfordshire
Posting date: 07 May 2019
QA.LP.23146_1557245046

An internationally leading contact logistics specialist is seeking for a Quality Validation Officer 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.

The QA Validation Officer will support the Quality Management team with the development, management and maintenance of the Quality Management System (QMS) within the company's Supply Chain-UK Healthcare. They will ensure compliance with Regulatory requirements, company's internal quality policies, and meet customer expectations, in particular developing, driving and delivering the Validation/Calibration processes (including GAMP).

Job Responsibilities:

  • 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 ensuring they are completed in a timely manner.
  • Supporting 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.
  • Performing other Tasks as instructed by the Quality Validation Manager & VP QA RCR UKI

Skills and Requirements:

  • The role holder must demonstrate knowledge of working within a Quality Management System associated with cGDP/ cGMP.
  • Demonstrated ability to successfully facilitate quality project work.
  • Experience on Validation/ Qualification and thermometric studies applicable to facilities and systems is preferable; however previous employment in Quality, QC or Engineering will be considered.
  • The Quality Officer should have knowledge and understanding of the pharmaceutical industry and Supply Chain elements.
  • Demonstrable project management skills.
  • 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.

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 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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