QA GVP Auditor
Location: SwitzerlandSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Biotechnology and Pharmaceutical organization, based in Basel-Stadt Switzerland.
Our client is specialized in orphan drugs.
ROLE DESCRIPTION
The preparation, coordination and performance of both external and internal audits against the business criteria, quality procedures, Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP).
RESPONSIBILITIES
- The production of audit reports and preventative action management
- Providing training and support to colleagues throughout the company in all scenarios regarding quality management, GCP and GVP.
- Leading and participating in projects to continuously improve the quality of GVP and GCP.
- Preparing regulatory authority assessments and audits
- Reviewing the company’s GCP and GVP related technical documents as well as Quality Assurance related documents.
- Worldwide travel of at least 60%
REQUIREMENTS
University Degree in Natural Sciences, medicine or related.
Several years of experience in drug safety, quality management or clinical development in a pharmaceutical environment.
Extensive knowledge of global GCP and GVP guidelines
Fluent in verbal and written English
Excellent analytical and communication skills
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact admin admin.
