Quality Auditor Computerized Systems

vor 2 Wochen

Darmstadt, Hessen, Deutschland Merck KGaA Darmstadt Germany Vollzeit
Work Your Magic with us


Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics.

Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility.

Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life.

Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.


Your role:


We're seeking a highly motivated and self-starting individual to join our diverse and very engaged Quality Auditing Team We offer a role with valuable insights into our Research & Development function and close interactions with various partners.

In this role you lead, coordinate, and participate in the organization and execution of Computerized System audits of different types focusing on the assessment of computerized systems within our company.

You perform data analytics during the preparation phase, prepare relevant, standardized audit plans, create audit reports, present audit observations, and follow up on those.

In addition to this, you take over projects to support the continuous improvement of the quality auditing function and to ensure audits are conducted consistently to high quality and in accordance with international and local pharmacovigilance regulations and guidelines.

Furthermore, you support the Inspection Management Team in preparation and hosting of inspections and inspection outcome follow-up.

Who you are:

***- University degree, preferably in a computer science or engineering-related field.

  • Meaningful professional experience in the aforementioned areas of responsibility (3+ years), preferably in auditing GxP relevant computerized systems like IVR/IWR, electronic Trial Master File (eTMF), imaging systems, central reader systems), PV databases/spreadsheets, other vendors with computerized systems (i.e. Overreaders such as ECG, CT-Scans etc.), system validation according GAMP 5 in the areas of Pharmacovigilance, GLP and GCP, Data Management, Electronic Data Capture (eDC), RWD/RWE and preferably additional GxP areas.
  • Strong ability to work in a structured way: good planning, project management and organization skills and having a serviceminded but goaloriented attitude
  • Great teammate with very good interpersonal and excellent communication skills; independent, motivated, responsible approach to work
  • User knowledge in PowerBI, MS Office 365, Veeva Vault, or similar software and curiosity regarding data analytics standards and advanced analytics.
  • Excellent oral and written communication skills in English and ideally one other language (preferred Chinese, Japanese or Spanish)
  • Willingness to travel globally (up to 15% travel time)

What we offer:
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.

We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology.

We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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