QA Associate Manager
vor 6 Monaten
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**:
**QA support for "Equipment & Automated Systems" projects**:
- Ensure that Equipment & Automated Systems implemented are in accordance with internal procedures and current guidelines/regulations (including procedures related to change, risk and deviation management).
- Support, review and approve Change Control Proposal (CCP) as QA Engineering for projects.
- Participate to risk assessment (FMECA, risk analysis associated to CCP)
- Review and approve quality documents (design documents, validation plans & summary reports, procedures, protocols, data reviews, reports and procedural documents which includes electronic forms)
- Ensure that validation, calibration and preventive maintenance programs are in place and are respected.
**QA support for "Equipment & Automated Systems" routine activities**:
- Review and approve quality documents (operational documents, procedures, forms, intervention report for automation activities...) for Equipment and Automated Systems activities.
- Ensure support for deviations related to Equipment and Automated Systems including QA assessment, investigation and CAPA review/approval and closure.
- Ensure that periodical interventions programs (validation, calibration and preventive maintenance plans) are in place and respected.
- Participate to annual reviews as required and ensure QA activities in SAP-PM system: equipment/system and maintenance plans creation/modification/removal.
**QA general support**:
- Review and assess GRT, Audit CAPA related to Equipment and Automated Systems activities in collaboration with management.
- Support department to guarantee that Equipment and Automated Systems procedures and forms are understandable and easy to complete and review.
- Participate to seminars and training sessions on Equipment and Automated Systems qualifications best practices to maintain "state-of-the-art" in house expertise.
- Ensure backup of the QA Engineering Projects team for projects and routine activities.
**Who you are**:
- Education: Bachelor's degree in Pharmacy or Engineering or equivalent
- Professional experience: at least 5 years of experience in Quality Management in Pharmaceutical Industry
- Knowledge in cGMP and Health Authorities expectations
- Proven experience with equipment and Automated Systems Qualification/Validation, Process Validation, Project Management and Computerized Systems Validation
- French and English fluent written and spoken
**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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