Validation Expert

vor 2 Wochen

Aubonne, 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.

**Your Missions**:
As Validation Expert responsible of
**Raw Material Management** for Fill & Finish department within the MSAT Team, you will:

- Manage raw material qualification (URS, coordination, documentation package, Critical Material Attribute assessment) in collaboration with supplier QA and QC according to Good Manufacturing Practices and Company's Quality Standards
- Be the technical point of contact for suppliers
- Identify alternative raw materials in collaboration with Purchasing
- Scout for technological innovations in raw materials
- Manage guidance & regulatory watch to detect proactively new requirements
- Manage Supplier complaints management and Supplier notifications (Change control) Management
- Contribute to the realization of CAPA/actions related to raw materials
- Manage raw material data base and its life cycle
- Work closely with QA, QC, production Participate in projects related to supplier quality assurance
- Participate in the maintenance of technology platforms and their development including harmonization between manufacturing sites
- Ensure an adequate personal management of her/his time and her/his activities
- Establish appropriate internal/external contacts for successful accomplishment of her/his tasks.
- Manage assigned projects teams to achieve the project objective within the agreed scope, time and quality
- Coordinate activities linked to raw materials
- Replacement of another expert to cover its most urgent/critical activities during his/her absence.

**EDUCATION/PROFESSIONAL EXPERIENCE**
- Master's degree in relevant fields (Chemistry, Pharmacy, Biochemistry, Engineering) with a minimum of 5 years of relevant industry experience.
- Good knowledge of pharmaceuticals business, of regulatory pharmaceutical guidelines (cGMP) related issues and Health Authorities requirements
- Good knowledge of F&F processes/unit operations
- Experience in international pharmaceutical companies
- Strong interpersonal skills and ability to interact positively and constructively with all functions in matrix organization environment.
- 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 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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