Tasks & responsibilities

Beyond performing Computerised Systems and GCP related audits as described above, your responsibilities include to:

• Support the organization in implementation and follow-up of corrective and preventive actions.
• Provide our business functions with QA and CSV/GCP guidance.
• Understand quality by design and further develop our risk-based approach in the auditing process.
• Prepare for and participate in regulatory inspections.
• Share best practices and ideas with fellow auditors on international level of Boehringer Ingelheim.

Requirements

• Master’s degree (or equivalent) in medicine, pharmacy, life science, or any other relevant field
• Several years’ experience in clinical trials coupled with multiple years’ experience in Computerised System Validation (CSV) and CSV Auditing
• In-depth knowledge of GCP regulations and legal requirements, ideally also experience in quality management
• Good communication skills in English (verbal and in writing), German language skills would be an asset
• Well-developed interpersonal skills are required. Open-minded and reliable personality, agile strategic thinker and being able to work independently as well as in a team
• Willingness to travel (inter)nationally, up to a maximum of 40%