GCP Auditor

☞ Boehringer Ingelheim

전망: 238

갱신일: 07-10-2024

위치: Ingelheim am Rhein Rhineland-Palatinate

범주: 매상 정보 기술 예술 / 디자인 제약 / 화학 / 바이오 테크 약사 / 제약 담당자 미용 / 스파

산업: Pharmazeutika Biotechnologie

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작업 내용

GCP Auditor-2110235

OUR COMPANY


At Boehringer Ingelheim 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 believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.


THE POSITION


As an Auditor in our Corporate Department Quality Medicine (QM), you will perform Good Clinical Practice (GCP) related audits in the areas of Clinical Operations, Medical Affairs, Translational Medicine, Biometrics and Data Management in various European countries. In more detail, this includes system and process audits, audits at investigator sites and at BI Operating Units, as well as audits at CROs and other service providers.

Being part of the global QM organization, you are a competent partner to our business functions in leading them to innovatively deliver high quality outcomes. As we aim for excellence in quality, you will guide them to manage and oversee the quality of their work.


Tasks & responsibilities


Beyond performing 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 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 with multiple years’ experience in GCP Auditing
  • In-depth knowledge of GCP regulations and legal requirements, ideally also experience in quality management and computer system validation
  • 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%


EFFECTS OF COVID-19


We will continue to hire talented people and we look forward to receiving your applications. As a result of COVID-19, we have introduced alternative working arrangements to ensure that our employees can stay safe and healthy, because the health of our employees is among our top priorities. At all company locations, we work remotely whenever possible. Additionally, we are now hosting virtual video interviews for applicants. During the limited in-person interviews we still have during this time, we pay special attention to distance and the hygiene rules recommended by the Robert Koch Institute. New employees who do not start on site in production or the laboratories are sent the necessary IT equipment, our Welcome Days take place online, and we plan to conduct their onboarding training virtually whenever possible.


WHY BOEHRINGER INGELHEIM?


This is where you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. To learn more about what benefits could be waiting for you, please visit our Career area.

Want to learn more about us? Visit https://www.boehringer-ingelheim.com/

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.


READY TO CONTACT US?


Please contact our Recruiting EMEA Team: Tel: +49 (6132) 77-173173

Not exactly the position you are looking for but have someone else in mind? Share it via the button on the bottom of the page with friends or colleagues who might be interested.

Job - Quality/Compliance
Primary Location - Europe-DE-Rhineland-Palatinate-Ingelheim
Organization - DE-Boehringer Ingelheim Pharma GmbH&Co.KG (Germany)
Schedule - Full-time
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마감 시간: 21-11-2024

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