Expert Inspection and audit management (m/f/d)
Posted 24 Nov 2023
Aubonne, Vaud - Switzerland
Req Id 262124
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)
- Train subject matter experts
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, well-organized and structured with excellent technical and analytical skills.
- Ability to drive collaborations with cross-functional teams to accomplish objectives.
- Personal accountability for results and integrity.
- Good project, time management and planning skills
- Solution based thinking and risk-based approach.
- Fluent 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!
Apply now and become a part of our diverse team!
US Equal Employment Opportunities
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.
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