Globally operating Quality Assurance consultancy is expanding its operations in Central Europe and is looking to appoint an experienced clinical QA specialist, who will be conducting independent GCP auditing in the region.
- Competitive salary;
- New challenge and professional development;
- High level of responsibility and independence;
- Flexibility to work from home;
- University Degree in Life Sciences or Quality Management;
- At least 2-3 years independent clinical investigator site auditing (GCP) experience (ideally backed by vendor, trial master file, systems or documentation audits);
- Sound understanding of the auditing process (planning, preparation, conduct, reporting), as well as drug development and clinical trial process;
- Solid knowledge of international regulatory requirements and industry guidelines in relation to GCP;
- Good attention to detail and ability to work independently;
- Fluency in English, both written and spoken (knowledge of other European languages would be an advantage);
- Computer literacy (Microsoft Office tools).
- Prepared to travel internationally (mainly Europe, with up to 2 audits per month).
Main Duties & Responsibilities
- Planning, preparing, conducting and reporting audits of clinical trials on medicinal products (e.g., investigator site audits, vendor audits, trial master file audits, systems audits, documentation audits);
- Handling of client enquiries throughout the execution of a contract;
- Contributing to continual company process improvements (e.g. through sharing of knowledge, peer reviews, delivery of informal internal training and co-audits);
- Providing advice and training to clients;
- Regular reporting to the regional QA Director.