### **Summary** The role is responsible for coordinating and managing activities related to analytical equipment, as well as providing scientific analytical support. This includes evaluating, developing, and validating methods required for raw materials and finished products. \~Performs qualitative and quantitative analyses of organic and inorganic compounds to determine the identity, purity, and homogeneity of pharmaceutical substances and related products for each project. \~Organizes and interprets all obtained data using a wide variety of instrumental technologies. ### **About the Role** Major Accountabilities \~Statistical analysis \~Support transfer projects \~Support for product and process validation \~Validation and qualification analysis \~Method transfer \~Implementation of new techniques/technologies \~Method optimization \~Equipment qualification \~Equipment calibration \~Equipment failure management \~Implementation of new technologies \~Preparation of equipment qualification plans \~Reporting technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt \~Distribution of marketing samples (if applicable) Key Performance Indicators \~No delays in registration and APR / PQR due to a defective stability study project \~No critical delays in study initiation \- approved protocol available on time, rapid storage of stability samples \~Stability study reports and evaluation documents available on time; adequate support for method transfer and other transfer projects \~Timely assessment and communication of transportation thermal excursions \~Additional KPIs defined within the management team \~Samples and associated documents delivered to laboratories on time. Work Experience \~Strong technical-scientific knowledge of pharmaceutical/chemical/QC analysis or equivalent Skills \~Laboratory equipment \~Quality control (QC) testing \~Quality control sampling \~Total Quality Management \~GxP \~Communication skills \~Industry standards \~Excellence laboratory \~Decision-making ability \~Managing ambiguity \~Self-awareness \~Continuous learning \~Technological competence Language English **Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people\-and\-culture **Benefits and Rewards:** Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits\-rewards Division Operations Business Unit Quality Location Mexico Site INSURGENTES Company / Legal Entity MX06 (FCRS \= MX006\) Novartis Farmacéutica S.A. de C.V. Functional Area Quality Job Type Full time Employment Type Regular Shift Work No
Juan García
Indeed · HR
Juan García
Indeed · HR
