QA Specialist

3 settimane fa


Guidonia Montecelio, Italia Merck KGaA A tempo pieno

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:
**Who you are:
- Master’s Degree in Technical scientifical field or equivalent
- At least 3 years of experience in pharmaceutical industry
- General knowledge of GMP Regulation for computer system (EU GMP-volume 4 annex 11; CFR21 part 11) and pharma industry (EU GMP volume 4, CFR21 part 210, 211)
- Fluent in spoken and written English
- Previous experience in complex organizations and international networks is in CSV/digital quality assurance
- Experiences in Quality area with knowledge on:

- Computer systems related quality processes (e.g. Change Control, Deviation, CAPA);
- Computerized system to analytical laboratory (e.g. CDS, LIMS)
- GAMP guidance
- GMP Regulation for computer system (EU GMP-volume 4 annex 11; CFR21 part 11) and pharma industry (EU GMP volume 4, CFR21 part 210, 211)
- Data governance and data Integrity principle s
- Problem solving and t eam working
- Precision and control
- Flexibility: planning and organizing
- Proactively identify areas for improvement within Quality Systems Knowledge of root cause analysis methodology, Lean Six Sigma and Quality Risk Management

**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


  • QA Specialist Mat. Leave

    4 settimane fa


    Guidonia Montecelio, Italia Merck KGaA A tempo pieno

    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...