Clinical Quality Auditor
Proclinical has partnered with a large successful biotech in search of a Clinical Quality Assurance. In this role you provide Clinical QA oversight, integrating Clinical operations into the company's Quality system. This role is a fantastic opportunity in Switzerland.
- Effectively plan and perform regular and random QA audits of clinical trials including but not limited to investigator site audits, audits of vendors, internal Operational audits in order to assure compliance with SOPs, study protocols, ICH GCP guidelines, relevant regulations and EN ISO 14155 requirements
- Manage and maintain databases for the quality system
- Become involved, when required, in project audit management and staff training and contribute to the review of the company's systems and procedures as appropriate.
- Have a thorough knowledge of all relevant SOPs, ISO requirements and appropriate regulations and guidelines.
- Develops the company's Quality Management System - focusing on implementing Clinical operations into QMS
- Evaluate/Manage quality issues, CAPAs, and complaints
- Participate in Inspection Readiness activities including hosting of Regulatory inspections and external audits
- Ensure that audit results are formally recorded and reported and that corrective/preventive actions are properly completed and documented.
- Assist with the development of project audit procedures.
Skills and Requirements
- Degree in Medicine,Technical/Scientific Studies, or equivalent
- 7 plus years of Clinical Quality Assurance experience in a Pharmaceutical, preferable in a Medical Device regulated environment
- Proven Auditing experience and experience with regulatory inspections
- Knowledge of regulations for Medical Devices, especially EN ISO 14155, ICH-GCP
- Willing to work in an international environment
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.