ProClinical is currently looking for a Quality Assurance Specialist to support a quality assurance function for one of our clients, a large medical device company. This is a contract role based in Switzerland.
This Quality Assurance Specialist job will involve:
- Ensuring that products, materials for production, systems and facilities are in state of sustainable compliance with the requirements of GMP and regulatory authorities.
- Review and approval of changes, CAPAs, NCs
- Review and approval of SOPs, WOIs, RARs and other quality controlled documents.
- Review and release of materials for production specification documentation.
- Qualification, review and approval of materials for production.
- Review and release of batch production records, including all supporting documentation (for example, test results)
- Compilation of batch dossier for batch release
- Experience in quality assurance of biological or pharmaceutical products according to GMP requirements
- University degree (FH/BSc/MSc) in natural sciences/medicine/pharmacy or professional scientific, medicinal or pharmaceutical training and several years working experience under GMP
- Knowledge of quality assurance principles (GMP), biological manufacturing processes and risk management
- Inspection experience
- Strong communication ability and good negotiation skills
- Analytical thinking and problem-solving ability
- Multilingual - at least German and English, written and spoken
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Beata Klecz on +44 203 0789 551 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.