Job type
PermanentLocation
HampshireWorking Pattern
Full-timeSpecialism
Quality Assurance And ValidationIndustry
PharmaceuticalsPay
36,000Closing date
20 May 2024
QA Specialist - IVD
Your new company
Your new company is a European Biotech with a strong UK presence. Specializing in clinical diagnostics, the company manufactures a diverse range of in vitro and molecular diagnostic tests, supplying assays and reagents globally.
This company plays a crucial role in the healthcare industry by providing rapid and accurate diagnostic solutions for infectious diseases. Their commitment to innovation, global surveillance, and collaboration with the scientific community is shown through addressing unmet needs and emerging threats.
Through organic growth, Biotech is looking to recruit a QA Specialist to contribute towards their global fight against infectious diseases.
Your new role
- Collaborate with team and across sites to ensure best practices are applied consistently across the organization in relation to the QMS.
- Responsible for providing/understanding of key metrics and developing reporting for identified QMS area to ensure health of QMS and identify improvements.
- Assure ongoing compliance with quality and industry regulatory requirements.
- Lead Quality activities such as risk management, change control, supplier assurance, deviations and CAPA management, document lifecycle, internal audits, and metrics reporting. This will require you staying up to date with corporate requirements, standard process and regulatory rules and regulations.
- Internal audits and audit reports.
What you'll need to succeed
- Experience with ISO 9001
- CAPA, Deviation, SOP, Change Control experience.
- QMS management and maintenance experience
- Life Sciences industry experience is essential
- IVD/ Medical Device experience is preferred
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.