Clinical Quality Assurance Specialist - GCP
ProClinical is currently recruiting for a Clinical Quality Assurance Specialist (GCP) on behalf of a leading drug discovery and development company focused on the creation of antibody-based drugs to benefit patients with inflammatory, auto-immune and other disorders. The Role is based in Basel and is dependent on experience, the QA Specialist will be reporting to the head of QA GCP.
- To act as clinical QA representative and provide QA guidance to support the clinical organisation to ensure compliance with GCP/GPV, and the clinical QA requirements
- To maintain and archive the clinical QA documents system, clinical QA systems, protocol deviation, investigations and change control
- To follow and track CAPAs related to audit, report metrics and monitor effectiveness
- To ensure that all clinical staff are properly trained on SOPs and the industry guidelines and regulations.
- To ensure that clinical QA training program and materials are maintained and archived and facilitate the training to clinical organisation
- To follow and track CAPAs related to inspection, report metrics and monitor effectiveness
Skills and Requirements:
- Bachelor degree in biological sciences, chemistry, or related field
- More than 3 years' active experience in Clinical Trials monitoring or Clinical Quality program, and training, CAPAs
- Practical working knowledge of GCP/GPV and all related EU & FDA regulatory requirements and ICH guidelines
- Ability to work effectively in a fast-paced environment and work effectively as part of clinical organisation team
- Ability to take pragmatic approach to problem solving
- Good verbal and written communication in English and in German or Italian will be an asset, and interpersonal skills
- Swiss resident or EU national
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 Courtney Russell on +44203 8141 315 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.