Quality Assurance Csv

vor 6 Monaten

CorsiersurVevey, Schweiz 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.

An exciting new opportunity has arisen to join us as
**Quality Assurance CSV & Data Integrity Expert** for our Biotech drug substance plant in Corsier s/ Vevey.

As an integral member of the Quality Unit, you provide QA expertise for the computerized system validation/Automation and data integrity. The role consists to elaborate the CSV/Automation & DI strategies, participates to risk analysis, identifies gap and purposes remediation plan. You act as Quality Subject Matter Expert on specific topics and participate in risk assessments and handle deviations on these topics as part of this new facility project. You review and/or approve validation documents (software and hardware), risk assessment, SOPs and take quality decisions according to company standards. With digitalization lots of projects are to come. Your will also present CSV & Data Integrity systems during inspections of Health Authorities.

The activities of the QA Expert cover all qualification phases from Basic Design until 1st use of equipment/software. You ensure GMP compliance during all phases of qualification/validation.

**Who you are**:

- University or relevant engineering degree
- Hands on experience of equipment qualification/computerized systems validation/data integrity in the pharmaceutical industry (GAMP 5, Eudralex annex 11...)
- At least 5 years' experience in a quality environment in pharmaceutical industry or equivalent
- Knowledge in cGMP and health authority expectations
- Experience in Equipement Software Validation (Production/QC equipment)
- Good interpersonal skills, with a positive attitude and the ability to support his colleagues in a context of growth and changes
- Good writing skills.
- French & English written & spoken.

**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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