Quality Assurance Digital Senior Expert

vor 20 Stunden

Aubonne VD, Waadt, Schweiz Merck KGaA 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:

  • Act as quality assurance expert supporting GxP IT/OT/digital systems implementation
  • Participate to Risk Assessment for Digital solutions addressing constraints of 21 CFR Part 11, Annex 11, GAMP 5 and global Regulation expectations
  • Participate to user requirements, design, risk assessment, computerized system validation, implementation, maintenance and monitoring of digital systems in accordance with required compliance expectations
  • Supervise and support change control process, deviation and CAPA for CSV activities
  • Improve quality CSV processes in use
  • Proactive participate to Data Integrity mitigation and remediation plans if required
  • Supports regulatory inspections as SME for QA CSV when needed

Who you are:

  • Master or bachelor level education within engineering, computer sciences, manufacturing or similar.
  • 15yrs+ experience in the development and implementation of IT/OT solutions in high-complex environment
  • Mandatory experience in a GMP or equivalent highly regulated environment (pharmaceutical, medical device, biotech, etc.)
  • Work experience as Project Manager or Team Leader in IS/IT projects
  • Work experience with ERP, MES, SDMS, LIMS, laboratory tools systems specifically integration to other systems/machines
  • Experience with lean / Six sigma will be an advantage
  • Highly desirable: good communication and leadership skills
  • Fluent in French and English

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

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity

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