Clinical Quality Auditor job in Lucerne, Switzerland

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Job type: Permanent

Discipline: Good Clinical Practice (GCP)

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

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.

Job Responsibilities

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

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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