Corsier-sur-Vevey, Vaud, Switzerland
6 days ago
GMQA-0, Senior Expert, Digital Quality

 

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 are thrilled to announce an exciting opening for the position of QA CQV Expert ! This is a fantastic opportunity to be part of a dynamic environment that is at the forefront of innovation and digitalization in the industry. Within the scope of computerized systems implementation, you will maintain and improve the quality management system related to Computerized Systems Validation (CSV) and Data Integrity, and ensure the compliance of the site with Health Authorities requirements and Merck Quality Standards for computerized systems implementation.

You will collaborate with the Digital and Quality Assurance project teams ensuring that all the deliverables meet quality specifications, and review and approval of GxP documents (including URS, traceability matrix, risk assessments, drawings, procedures, qualification and validation documents). You will have the opportunity to promote continuous improvement and drive innovative solutions in a supportive and collaborative environment.

For this expert position, we are looking for a passionate leader who can inspire a culture of quality excellence throughout the site.

YOUR PROFILE

Graduate background plus substantial to extensive professional experience in relevant disciplines (mature professional),Senior knowledge and experience in own discipline and beyond. At least 8-10 years’ work experience in quality assurance, Quality Management, IT Compliance or equivalent,  Demonstrate proficiency and thorough knowledge of computer system validation (CSV) and Data Integrity requirements defined by applicable health authorities and/or industry groups,Thorough knowledge of quality management and CSV (cGxPs, 21CFR Part 11, Annex 11, GAMP) aspects of computer system applications,Thorough knowledge of regulatory requirements (FDA, EMEA, ICH), Demonstrates attention to detail and organizational skills,Autonomous, organized and quality driven with good communication skills,Results driven with a strong customer and quality focus,Fluency in English mandatory, knowledge of French a plus.

 

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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