Aseptic Operations Expert

vor 10 Stunden

Aubonne, Schweiz Merck KGaA 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 role:
As an Aseptic Operations Expert you are responsible for ensuring that the aseptic practices/activities in place in the Fill & Finish department are in compliance with relevant GMP.
- Definition and implementation of the APS (Aseptic Process Simulation or Media Fill) strategy on aseptic production lines: ensure on the floor oversight and organization of each APS in compliance with GMP rules and procedures in force.
- Elaboration and drafting of the operational documentation required for the successful completion of APS activities (Risk Assessments, Protocols, Reports, Annual Plans, etc.).
- Collaboration in the organization, management and execution of air flow visualization studies (AVS or “smoke tests”): definition of strategy, drafting of related operational documentation, supervision of the activity.
- Observing the aseptic behavior of production operators, to ensure the quality of aseptic operations carried out by those involved in the aseptic core.
- Carrying out training courses on good practice/aseptic behavior for staff working in the aseptic core.
- Management of deviations, CAPA, Change Control within the scope of activity
- Represent your activity in the event of regulatory audits/inspections (EMS) Participation in assessing compliance with current regulatory requirements (Annex 1 EU GMP, FDA Guidelines etc.) and future updates, assessing any gaps and guiding the implementation of identified best practices

**Who you are:
- Education in biotechnology, or equivalent
- Mastery of the pharmaceutical environment and in particular of aseptic filling processes and aseptic practices (3-6 years experience)
- Knowledge of Good Manufacturing Practices (BPF / GMP), in depth knowledge of Annex 1 EU GMP
- Editorial quality (Procedures, risk analyses, deviations, etc.)
- Team spirit, leadership, autonomy, proactivity, and good communication are qualities necessary for success French mother tongue/fluent - Good level of English (minimum B2)

**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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