Product Quality 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 Product Quality Manager. This role can be based in either East Anglia or Scotland.
The role is to manage the UK product quality programme. This will involve being responsible for the final release of all UK production batches, the auditing of UK production processes, managing updates to documents related to production and QC issues, implementing a programme of continuous improvement within the relevant departments, ensuring product and process changes are carried out in a controlled and systematic manner.
‐Be responsible for the final sign off and release of all production batches from the UK production sites.
‐Be assured that the production and QC processes involved in the manufacture of these batches has been conducted in a way that ensures the principles of cGMP have been followed.
‐Conduct appropriate audits of these production and QC processes to ensure that cGMP principles are consistently being applied.
‐Make recommendations to documentation practices and production and QC processes that will instil a culture of continual improvement in the UK production and QC areas.
‐Ensure that any changes coming out of a continual improvement programme are carried out in a controlled and systematic manner.
‐Ensure all change notifications that relate to production and QC are closed out prior to release of material
‐Manage all CAPA activities that relate to production and QC
‐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 working under regulatory, quality and design systems requirements as applicable for the in-vitro diagnostics industry is important.
Location: Based either East Anglia or Scotland
Salary: Negotiable + Benefits
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- Agency: SCI Recruitment for Scientists
- Posted: 3rd August 2017
- Expires: 31st August 2017
- Reference: 19589