**Senior GCP Auditor - Global Biotech, Geneva**
Excellent Salary, Bonus + Package| Geneve| Permanent
A well known and expanding Global Biotech is actively looking for a Senior GCP Auditor to join the team, based in Geneva! The company are moving through a very exciting period of growth, due to some fantastic products within their pipeline. The Senior GCP Auditor will hold experience of conducting Global GCP Audits including Site Audits, and they will also hold working knowledge of how to develop and implement a strong audit program! The company can offer excellent opportunities for progression.
This position is responsible for providing audit support and GCP oversight of Clinical Development teams to the Head of QA-GCP. This job will include the execution and management of QA-GCP audits and the provision of GCP guidance and advice across relevant Clinical Development groups.
Duties and Responsibilities
- Plan, schedule and conduct audits of Clinical Investigator Sites, CROs, and Clinical submission documents.
- Coordinate responses and corrective actions from audit findings.
- Provide GCP advice and support to Clinical Operations and other relevant functions.
- Stay abreast of EU clinical trial requirements, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the EU and other regions, as appropriate.
- Assist in the review and revision of Clinical Development and QA SOPs.
- Conduct GCP training.
- Alert QA GCP Management of internal and external GCP compliance and clinical trial issues in a timely manner.
- Become thoroughly familiar with assigned compounds and protocols.
- Provide support for regulatory authority inspections including conducting pre-inspection audits of sites.
- Assist with the management of QA consultants performing audits on behalf of the company.
- Bachelor’s degree
- 5 – 10 years’ experience in a pharmaceutical or bio-pharmaceutical company in a GCP QA role with a minimum of 5 years’ experience performing GCP audits of CRO’s and investigator sites.
- Ability to travel up to 40%.
- Strong written and oral communication skills.
- Prior inspection experience preferred.
For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!
Sam Caley - Advanced Clinical Recruitment
LinkedIn Search: Sam Caley Quality Assurance
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