Senior QA Officer - Birmingham
Naynesh Mistry has an exciting opportunity and is recruiting for a Senior QA Officer to join a leading specialised medical diagnostic company based in Birmingham on a permanent basis. Our client engages in the research, development, manufacture, and distribution of immunodiagnostic assays for the laboratory market.
ESSENTIAL: Successful candidate must have QA experience from a regulated QA commercial environment i.e. Pharma, or medical devices. Additionally they must possess team leading/man management experience i.e. staff appraisals, budget responsibility etc, as it is expected for this role to have up to 3 directs in the near future.
This is a new role where the successful candidate will be responsible to ensure compliance with the QMS to make sure that manufacturing have carried out the work ensuring products are fit for purpose. You will support the quality team in reviewing the Batch Manufacturing Record. They will also support the wider QA department in ensuring that the quality management system meets all requirements of all relevant regulatory standards and Regulations: (ISO9001/13485, FDA CFR 820 part 21, QSR's) and supports the manufacture of consistent quality product.
- Line management of the QA Batch Release team within the Quality Administration Group, including ensuring all members are properly trained for their duties.
- Degree or equivalent in Biological sciences or similar.
- Experience in working in a regulated industry (Pharma or Medical Device).
- Supervisory experience.
- Functional QA or QC position within a regulated industry.
- Currently working in a similar QA release role.
- Good understanding for Quality principles / Quality systems.
- Audit experience.
- Quality Assurance system background.
- Training to ISO 9001/13485 or 21CFR part.
To apply for this position contact Naynesh Mistry on 01246 457700 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45777 in all correspondence.