Expert Inspection and Audit Management

vor 1 Woche

Aubonne VD, Waadt, 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.


Your role:

You will act as process owner for the site inspection / audit management and be responsible to:

  • Lead Inspection / audit Readiness Program
  • Manage inspection from Health authorities and customer audits: from preparation until final report and definition of relevant CAPA plan.
  • Ensure timely completion and effectiveness of audit/inspections related Corrective and Preventive Actions (CAPAs)
  • Escalate compliance issues/risks to Senior Management as appropriate
  • Ensure inspection readiness for upcoming Pre-Approval Inspections associated to the introduction of the new isolator technology (SKY Project)

Projects:

  • Continuous improvement of area under your responsibilities
  • Automatization of routine tasks (with tools like Power Apps, Power Automate) and processus
**Who you are: - University degree (min Master) in scientific education, 8 + years in pharmaceutical industry.

  • Experience of working with GXP audits/inspections and experience in manufacturing processes and with isolator technology
  • Experience with inspection from health authorities
  • Excellent communication and presentation skills dealing efficiently with all levels of the organization.
  • Ability to work both independently and collaboratively, wellorganized and structured with excellent technical and analytical skills.
  • Ability to drive collaborations with crossfunctional teams to accomplish objectives.
  • Personal accountability for results and integrity.
  • Good project, time management and planning skills
  • Solution based thinking and riskbased approach.
  • Fl uent in French and English

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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