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 adaptable working culture, presenting great opportunities for personal development and career advancement across the globe.
We are looking for a **Quality Specialist** to support regulatory compliance activities, reporting to the Quality Manager. This role ensures alignment with **COFEPRIS regulations** (NOM-059, NOM-072, NOM-240, NOM-241), **GMP/GDP standards**, and audit readiness.
**Your Rol**:
- Ensure compliance with local health regulations and support **COFEPRIS inspections**.
- Manage deviations, CAPAs, complaints, change controls,



and product alerts.
- Maintain and improve the **Quality Management System** (QMS) using **TrackWise**, **SAP**, and **Power BI**.
- Oversee warehouse and logistics operations: inspections, calibrations, relabeling, and storage compliance.
- Coordinate product release, returns handling, and lifecycle management.
- Support validation (equipment, cold chain) and **pharmacovigilance** reporting.
- Conduct audits of **clients and suppliers** to ensure compliance.
- Deliver GxP training and contribute to crisis and recall management.
**Who you are**:
- Degree in Pharmacy, Chemistry, or related field (QFB, QFI).
- 4-9+ years’ experience in pharmaceutical quality or regulatory roles.
- Proven experience with **GMP, GDP, COFEPRIS**, and **client/supplier audits**.
- Strong organizational, communication, and problem-solving skills.
- Self-driven and detail-oriented.
- Location: Cuautitlán Izcalli
**What we offer**: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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!

📌 Especialista de Calidad (Naucalpan de Juárez)
🏢 Merck Group
📍 Naucalpan de Juárez