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QA Engineer DP (m/f/d)
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.
We are looking for a QA Engineer DP at our site in Aubonne for:
- Participate on QA oversight for Fill and Finish activities.
- Participate on aseptic filling investigations in order to strongly assess all quality risks.
- Ensure that semi-finished products and diluents, manufactured internally or externally, for market meet the appropriate quality requirements and are in compliance with current Good Manufacturing Practices (cGMP’s), any applicable regulatory filings and Merck Quality Standards.
- Manage the change control request and ensure that semi-finished products and diluents delivered on the market are in compliance with the Regulatory Constraints.
- Review the Manufacturing Batch Records / documentation and recommend the release of semi-finished products and diluents manufactured externally and at Aubonne.
· To perform usage decision of commercial semi-finished products and diluents manufactured at Aubonne or externally manufactured after documentation review.
· To edit Certificate of Analysis of commercial semi-finished products and diluents manufactured at Aubonne.
· To review and close out investigations with regard to deviation and ensure that preventive and/or corrective actions are implemented as appropriate.
· To review and approve manufacturing procedures and documentation associated to the manufacture of semi-finished products and diluents (e.g. Procedures, Modèles de production, Master Batch Record…)
· To take part into internal audits and auto-inspections.
· To contribute to Customer complaints investigation.
· To evaluate and approve all manufacturing change requests and ensure that semi-finished product and diluents delivered on the market are in compliance with the Regulatory Constraints.
Monitoring and validation
· To sign-off Validation Plan, User Requirements Specifications (URS), Performance Qualification protocols and reports, validation protocols and reports concerning FDF Manufacturing Unit
· To review the documentation relative to Aseptic Process Simulation, Smoke test studies and maintenance operations during the shut-down and approved the relative reports.
Regulatory and Health Authority inspections
· To provide answers to technical requests coming from the Quality Unit Regulatory Affairs.
· To contribute to Health Authority Inspections
- University degree with minimum 3 years of experience in Pharmaceutical industry, with preference in Aseptic filling industry.
- Experience in Quality Assurance.
- Fluent in French and in English
- Purposeful, Results-driven, and Collaborative.
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!