about 2 years ago
Job title: Senior Quality Assurance Officer - Contract
A Pharmaceutical business in Berkshire are seeking an immediately available Quality Assurance Professional. Pharmaceutical product experience is essential, with medical devices experience being desirable.
This is a contract role with the opportunity to move permanent.
- Ensure that incidents, deviations, complaints and other quality system requirements are captured, reported and fully investigated and root cause established
- Author, review and approve deviations, CAPA, Change Control, Risks and other Quality Systems elements.
- Manage Supplier Assurance process including management of the external audit schedule, negotiation and management of Technical Agreements, oversight of suppliers and service providers, liaison with corporate supplier management, and support of supply chain mapping and route assessments.
- Technical review/approval of supplier documentation e.g. CAPA, Deviation, Change Control, Batch Records
- Experience in the manufacturing, quality assurance and quality control of medicinal products, including knowledge of Quality Management systems, experience in sterile product manufacturing would be an advantage.
- Foundation knowledge of applicable MHRA/EU GMP Guidelines
- Experience of working in with Investigational Medicinal Products in the EU
- Experience of working in an EU GMP regulated environment (Pharma and/or Device)
- Experience of working in an ISO13485/Medical Device regulated environment
Salary and benefits:
A competitive day rate is on offer. Opportunity to move permanent.
To apply for this position or hear further details then please contact Matt Thomas via email@example.com