CSV Auditor (m/f/d)

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Boehringer Ingelheim
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November 04

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%
Skill & Language
Quality
1 - 3 years
Negotiation
1 candidate
December 06
Full Time
Executive
Insel, Rhineland-Palatinate
Boehringer IngelheimPharmaceuticals Ingelheim am Rhein5 jobs · Biberach an der Riß, Baden-Württemberg
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Privately Held
1995
10001+ employees
About Company
OverviewAt Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We are powered by 52.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key, because your growth is our growth. Want to learn more? Visit www.boehringer-ingelheim.com and join us in our effort to make more health.
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