Clinical QA Auditor
A large commercial-stage oncology company is in search for Clinical Quality Assurance Auditor. This is a home based role, but is an exciting opportunity to join a fantastic organisation.
- Effectively plan and perform regular and random QA audits of clinical trials including but not limited to investigator site audits 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 systems and procedures as appropriate.
- Have a thorough knowledge of all relevant SOPs, ISO requirements and appropriate regulations and guidelines.
- Develops the 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 environment
- Proven Auditing experience and experience with regulatory inspections
- Knowledge of regulations for Medical Devices, especially EN ISO 14155, ICH-GCP
- Fluent English is a must-have, German is an asset
- 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.