QA Engineer - Expert 2- All genders

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 a key member of the QA OPS Production team, you will be responsible for ensuring compliance and documentation of manufacturing activities at our facility. You will work closely with Production teams and support functions such as Data, Engineering, Maintenance, and Supply, as well as the release process.

Key Responsibilities:

• Serve as the QA point of contact for deviations, providing necessary requirements for associated investigations.
• Evaluate and close minor and major deviations while identifying recurring trends.
• Assist in defining and approving corrective and preventive actions (CAPA).
• Review and approve GMP-related documentation pertinent to your role.
• Monitor and approve cGMP documentation and change proposals (CCP).
• Actively participate in health authority inspections and internal and external audits.
• Meet quality indicators to ensure timely lot release, effectively serving our patients and clients.
• Provide QA expertise in Process Validation, with involvement in Equipment Qualification, Cleaning Validation, Raw Material Qualification, and Computerized System Validation as needed.
• Develop qualification/validation strategies and review/approve related protocols and reports.
• Participate in risk analyses, identify gaps, and propose remediation plans.
• Act as a Quality Subject Matter Expert on specific topics and support risk assessments and deviation handling.
• Oversee qualification/validation phases from Basic Design until the first use of equipment/raw materials, ensuring GMP compliance throughout all phases.

Your Profile:

• Education: Degree in Life Sciences, Engineering, or a related field (e.g., Biochemistry, Biotechnology, Pharmaceutical Science).
• Experience: Minimum of 4-9 years of experience in the pharmaceutical or biopharmaceutical industry, specifically in a GMP-compliant manufacturing environment.
• Knowledge: Excellent understanding of cGMP guidelines and regulatory compliance requirements; solid knowledge in Process Validation and familiarity with Equipment Qualification, Raw Material Qualification, and Cleaning Validation is a plus.
• Skills: Strong analytical mindset with experience in risk assessment, deviation handling, and remediation planning. Excellent organizational skills with the ability to review and approve technical documents such as protocols, reports, SOPs, and risk assessments.
• Languages: Proficient in French and English, both written and spoken.
• Personal Qualities: Recognized for assertiveness, effective teamwork, and proactivity in implementing improvements. Results-oriented and committed to achieving quality objectives.

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!