Quality Coordinator
hace 5 días
Quality Coordinator**Category**:Quality**Location**:Ciudad de México, Ciudad de México, MX**Your new role**- As a Quality Coordinator at Novo Nordisk, you will:- Maintain and improve the Novo Nordisk Quality Management System (QMS) to meet internal and external requirements.- Coordinate and oversee Good Storage and Distribution Practices (GDP) within logistics partners in Mexico, ensuring compliance for product handling, cold chain management, and warehouse conditions.- Provide QA disposition for arrived and returned products after verification of product inspection and temperature records.- Lead quality projects, including supporting the qualification and validation of cold rooms, transport solutions and GxP IT systems ensuring quality compliance for innovative business models.- Manage deviations and change controls within cross-functional teams, facilitating root cause analysis, risk assessments and CAPA execution.- Ensure accurate documentation and records management for local GxP documents and business critical records.- Support the Quality Responsible Person by monitoring local regulatory requirements and leading its implementation.- Attend Health Authority inspections, internal and external audits ensuring effective communication with all interested parties, support affiliate with the definition of CAPAs and its completion.**Your new department**- This role is based in Mexico, where you will be part of a dynamic and collaborative team dedicated to ensuring the highest standards of quality across the value chain. Our team is committed to compliance, innovation, simplicity and continuous improvement, working together to make a meaningful impact on patients’ lives. The atmosphere is fast-paced and supportive, with a shared focus on delivering excellence in everything we do.- Your skills and qualifications- Must have:- University degree, preferably in Life Sciences, Pharmacist, Pharmacobiology Chemist.- Advanced English level (required).- 3 to 5 years of experience in Quality Assurance in the pharmaceutical industry, ideally as a Quality Coordinator, Quality Analyst, or Quality Specialist.- Mandatory experience in Good Distribution Practices (GDP) and cold chain management.- Experience in quality management systems (QMS) and their implementation/maintenance.- Knowledge of COFEPRIS regulations NOM-059-SSA1-2015, NOM-072-SSA1-2012, FEUM.- Experience in Quality Assurance including storage and distribution, not laboratory Quality Control.- Project and stakeholder management skills.- Residence in Mexico City with availability to travel 2-3 times per week to Cuautitlán Izcalli.- Nice-to-have:- Experience in a multinational pharmaceutical company.- Experience with supply chain.- Use of tools such as Viva Vault or TrackWise.**Working at Novo Nordisk**- Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.**What we offer**There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcarecompany means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.**More information****Deadline**- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.- We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
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Quality Coordinator
hace 5 días
Ciudad de México Novo Nordisk A tiempo completoQuality Coordinator **Category**:Quality **Location**:Ciudad de México, Ciudad de México, MX **Your new role** - As a Quality Coordinator at Novo Nordisk, you will: - Maintain and improve the Novo Nordisk Quality Management System (QMS) to meet internal and external requirements. - Coordinate and oversee Good Storage and Distribution Practices (GDP)...
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Quality Coordinator
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