QA Operations Expert

vor 5 Monaten

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:
- To ensure support to MES design and deployment in Aubonne packaging department.
- To ensure system validation and maintenance related to QA Pack systems (MES, SAP and SCP, Certisafe (release tool))
- To manage monitoring of Quality Assurance Operation performance.
- To provide the information needed for the release of products and/or production packed on Aubonne plant.
- To provide support to the packaging department in order to comply with the cGMPs and ensure a QA oversight on packaging activities
- To perform the review of documentation and batch record linked to product packed on Aubonne plant
- To ensure the QA follow up of the Change Control Proposal, CAPA and Deviations related to packaging activities with high quality level in the content of CCPs/Deviations/CAPAs/CCP Actions
- Provide QA Operations on-call duty for the Packaging activities
- Support packaging projects as QA and follow implementation of the projects

**Your Ideal Profile:
- University degree (MSc, Engineer or PharmD) in a life science discipline (Pharmacy, Life science)
- 5-10 years experience in pharmaceutical industry (production and/or quality)
- Strong knowledges in ICH and GMP regulations
- Experience in packaging activities is preferred
- Ability to work in a global matrix environment

**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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