Quality Assurance Expert

vor 5 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.

**Quality Assurance Expert**

Are you a dynamic Quality Assurance Expert looking for new challenges? Are you interested in joining an innovative Development and Clinical Manufacturing plant newly created?

An exciting new opportunity has arisen to join the Biotech Development Center Quality team as Quality Assurance Expert to establish and maintain compliance in the Quality Control laboratories.

We are looking for a highly motivated individual being the QA referent for the operational activities of the QC responsible for establishing and maintaining the compliance of laboratory with Good Laboratory Practices and internal procedures within the context of development and clinical manufacturing
***:
**Your Role**
- Supports definition of the GMP/GDP strategy for development activities including pre-GMP activities
- Implements & ensures alignment of local Quality Control and Development Activities with GMP documents and Regulation
- Oversees Quality Control activities for clinical product testing and release (Drug Substance)
- Oversees Compliance of the environmental monitoring of areas
- You will also work on projects to continuously improve the processes.

**Who you are**:

- Degree in a Life Science or related discipline such as pharmacy, biochemistry, chemistry or other relevant (minimum MSc or equivalent degree),
- At least 5 years work experience in pharmaceutical sciences
- Min.of 2 years work experience of new product development and know-how of product launches in development, with QC background
- Experienced in project management (as lead or team member)
- Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents, and other Regulations
- Strong interpersonal and leadership skills
- Fluency in English and French (written and spoken)
- Results driven with a strong customer orientation and quality focus
- Good flexibility in a changing 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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