Quality Assurance Expert
vor 11 Stunden
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.
As an integral member of the Quality Unit, you provide QA expertise for Raw Material Release, Supply & Logistics Operations, Biotech Manufacturing Compliance and Drug Substance Release.
**Your Role**:
- Oversee Compliance of the Logistics & Manufacturing by reviewing data, deviations, and change controls
- Release Raw Material for Production
- Preparation of Dossier for Drug Disposition Release
- Ensure OOS, deviation, change control processes are properly followed, provide QA decisions and approval for these exceptions. Ensure that investigations determine root causes, impact assessments and appropriate preventative/corrective actions. Ensure timely closure of investigations, and proper escalation to management as per local and global procedures
- Monitor QA process and manage communication and reporting according to a defined frequency
- Support employee training to diffuse new regulations and policies
- Support audits and inspections as required Participate in improvement projects as a team member, and as a team leader
**Who you are**:
- Degree in a Life Science or related discipline such as pharmacy, biochemistry, chemistry or other relevant (minimum MSc or equivalent degree)
- 10 years of experience in a pharmaceutical/biotechnology environment, with 5 years of Quality Experience in Material Release
- Broad experience in working with other quality professionals in new product development and know-how of product launches in development
- Deep knowledge of Health Authority regulations and proactive approach to all aspects of Quality
- Thorough experience in the usage of Merck IT systems (mandatory: CARA, TW and SAP Lean, beneficial: MES PASX
- Strong interpersonal and leadership skills
- Excellent communication skills and very good command of English and French (written and spoken) Flexible team player, who is curious to learn, proactive in sharing and collaborating
**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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