Quality Specialist

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:

• Support the Quality Manager in executing Quality and Compliance tasks for the Mexico branch, ensuring adherence to Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP), as well as local regulations including NOM059, NOM072, NOM241, and NOM240.

• Assist in the implementation and monitoring of the Quality Management System and its continuous improvement, aligned with the global Healthcare Operations strategy.

• Manage and report on product release, complaints, deviations, CAPA, change control, and product alerts, including notifications to Cofepris.

• Ensure that returned product documents are available in the EPR, and maintain records and investigations of complaints through TrackWise.

• Manage the complaints process, including investigations with assigned sites and sample returns to manufacturing sites.

• Compile, track, and share trend reports, proposing CAPAs in collaboration with stakeholders.

• Support the product launch process, ensuring final release in local markets (specialties: endocrinology, neurology, fertility, oncology; general medicine: cardiometabolic care).

• Evaluate product returns and determine their suitability for resale or destruction.

• Assist in preparing training presentations on relevant GxP SOPs and WIs.

• Recognize and report adverse events, ensuring communication with the Local Patient Safety Responsible Person (LPS).

• Assist in the reconciliation process of adverse events and product complaints.

Main Responsibilities:

• Deviation & capas (management & backlog solving, close – out)
• Chanf control process
• KPIS Monitroing tier 1 & tier 2
• Mock Recall / Recall
• Tecnovigilancia
• Documentation updating & managmenr (archive & effective)

Your Profile:

• Degree in Pharmacy, Chemistry, Life Sciences, Pharmacology, Medicine, or related scientific disciplines.

• 4 to 9 years of experience in the pharmaceutical industry, preferably in manufacturing/quality operations or distribution management.

• Experience with Good Distribution Practices.

• Proficiency in Microsoft Suite.

• Familiarity with software such as Veeva and ManGo, and document management systems (highly desirable).

• Experience with data analysis tools such as Power BI.

• Advanced English (required).

• SAP (required).

• TrackWise (required).

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!