Quality Associates – In vitro Diagnostics
Our client is a well-established and highly-respected in vitro diagnostics manufacturer, with sites in Scotland and East Anglia. As a direct result of continued growth, they now wish to appoint Quality Assurance Associates to be based in either location.
The roles will be for product quality, quality systems or quality validation. Depending on the specialism key responsibilities and experience will be as follows:
• To be involved that all final batches are fully prepared for final sign off
• Ensure the production and QC processes involved in the manufacture of the batches ensures compliance with cGMP
• Be involved in audits of these processes and that cGMP principles have been followed
• Work within a culture of continual improvement
• Be involved in CAPA activities that relate to manufacturing and QC
• Execute document control systems throughout the site
• Ensure the internal audit schedule is fully compliant
• Execute the vendor audit programme effectively and maintain the supplier management programme
• Ensure the smooth running of regular external audits
• Adhere to the change control systems for the site
• Ensure CAPA systems are running effectively
• Maintenance of the validation master plan for the site, ensuring protocols meet industry regulations.
• Ensure equipment qualification for the site – proactive and retrospective
• Ensure requalification programme for the site as necessary.
• Execute process validation plan for the site
• Ensure the cleaning validation plan is executed.
• Ensure the execution of the software validation plan including bought in software and that developed in-house.
Experience and Qualifications
· Degree level or equivalent in a relevant scientific discipline
· Ideally experience in an IVD or medical device manufacturing environment
· Experience of working with Quality Management Systems
· Experience of working with external auditors such as the FDA
· Experience of working under regulatory, quality and systems requirements
· Experience with one or more of the following: quality systems; quality validation; product quality.
Location: Based Scotland or East Anglia
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