Quality Validation Manager – In vitro Diagnostics
Our client is a well-established and highly-respected in vitro diagnostics manufacturer. As a direct result of continued growth, they now wish to appoint a Quality Validation Manager to be based in East Anglia
The role is to manage the UK Validation programme for the company sites, and will include development of an equipment qualification programme, a process validation programme, and a software validation programme. The role will also input and contribute to the other company site’s validation programmes as required.
‐ Produce and maintain validation master plan VMP for UK sites and ensure validation protocols meet current regulations
‐ Manage the Equipment qualification for sites in the UK
‐ This is to encompass both proactive and retrospective equipment qualification.
‐ To plan and execute a suitable requalification programme for both sites.
‐ To develop a comprehensive process validation plan and schedule for the UK sites.
‐ To translate the process validation results into appropriate process capability measures.
‐ To ensure cleaning validation programmes are in place at sites.
‐ To plan and execute a software validation plan to encompass both bought in software and in house developed routines and scripts.
‐ To assist and advice the other manufacturing sites on validation matters.
‐ Liaise with the other Quality professionals within the UK organisation
‐ Assist in the instilling of a Quality Culture ethos within the entire organisation.
You will have a Scientific qualification, degree or higher level degree, with experience in an in-vitro diagnostic Quality Management environment. Experience of organising and executing a validation programme within an IVD or Medical Device environment and of working under regulatory, quality and design systems requirements as applicable for the in-vitro diagnostics industry is required.
Location: Based East Anglia
Salary: Negotiable + Benefits
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- Agency: SCI Recruitment for Scientists
- Posted: 3rd August 2017
- Expires: 31st August 2017
- Reference: 19588