Product Assurance Specialist

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 Role:

You ensure the integrity of environmental monitoring by verifying microbiological plans for classified areas. You analyze cleanroom contamination data, pinpointing improvement opportunities and optimizing control. You lead investigations into contamination limit breaches in production zones. You deliver ongoing training on regulatory standards for environmental monitoring and GMP. You develop risk assessments and qualification documents for classified spaces. You maintain compliance through document creation and updates. You drive quality assurance process improvements. You present data to internal and external parties, including regulatory bodies. You assist in evaluating deviations on the production floor.

Who You Are:

• Degree in Biology, Biotechnology, Microbiology, or a related science.
• Experience in Quality or Sterility Assurance within sterile pharmaceutical production, specifically in cleanrooms or isolators.
• Proficient in risk analysis methodologies.
• Minimum of two years of relevant experience.
• Strong interpersonal and negotiation abilities, precision, and a proactive learning approach.
• Skilled in using computerized systems for specialized business software (SAP, LIMS, Trackwise).
• Fluent in English.
• Deep understanding of GMP, especially Eudralex Annex 1.

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!

Apply now and become a part of our diverse team!