Quality Auditor Computerized Systems (all genders)

Posté 01 juil. 2022

Darmstadt, Hessen - Germany

Demander un identifiant 251879

Détails

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

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 quality 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 informatics, system validation according GAMP 5 in the areas of Pharmacovigilance, GLP and GCP, Data Management, Electronic Data Capture (eDC), 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. Over-readers such as ECG, CT-Scans etc.), RWD/RWE and preferably additional GxP areas

  • High curiosity regarding data analytics standards and advanced analytics

  • Extensive experience in converting data into business insights by processing large amounts of data and scaling of algorithms or developing user-friendly application interfaces in Python

  • Strong ability to work in a structured way: good planning, project management and organization skills and having a service-minded but goal-oriented 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

  • Excellent oral and written communication skills in English and ideally one other language (preferred Chinese, Japanese or Spanish)

  • Willingness to travel globally (up to 25% 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. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html

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