Job Title: Stability Program Officer. Introduction to Role: Join us as a Stability Program Officer in our Operations team. In this role, you will provide Quality Assurance support to an assigned area, offering technical advice in key areas of processes and procedures. You will directly impact the value stream by ensuring efficient processes and procedures are maintained within the boundaries of regulatory compliance. This is a non-supervisory role, ideal for a graduate or someone with equivalent experience.
Accountabilities: Collation, review, and approval of submission-ready stability data.Create data reports and update stability studies in LIMS.Lead minor change controls and detect and raise deviations.Update documents such as Standard Operating Procedures, Stability Protocols, Stability Product Documents, External Stability Protocols, presentations, and training materials.Essential Skills/Experience: LIMS and data management knowledge (Labware).Schooling in Chemical/Biological areas (Chemical Engineer, Pharmaceutical Chemist, or similar).Knowledge and handling of national and international pharmacopoeias, as well as knowledge of national and international pharmaceutical regulations (USP, ICH, PIC/S).Desirable Skills/Experience: Experience in laboratory analysis and knowledge of drug development (different pharmaceutical forms).Applied statistics.Strong English communication skills required. Positions are open to Mexican Citizens and official residents of Mexico. Location: Guadalajara (hybrid - Expectation of working in the office 3 days a week)
At AstraZeneca, we take Quality seriously. Our work is meaningful and valued. We are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. We are a team of bold people who want to go far. We are proactive, science-based, and solutions-oriented. Our focus is on scaling and introducing new technologies, using models to predict and proactively handle risk. We work cross-functionally, across sites and regionally, sharing expertise and offering support to others. We follow evidence to reach outcomes that benefit patients and AstraZeneca.
Join us and be the voice of the patient. Be proud to play a meaningful role as the eyes and ears of our patients. All our contributions add up to improving the quality of patients' healthcare and ultimately their quality of life.
Ready to make a difference? Apply now!
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