About this role
Job Description 1. Preparation of an annual stability program in compliance with NOM-073-SSA1-2015. 2. Verification of compliance with the annual stability program, as well as with programs derived from stability studies required by Regulatory Authorities (AR) for Marketing Authorization Renewals (MCR) and/or regulatory filings. 3. Verification that the maintenance, qualification, and use of in-house climatic chambers align with established programs and procedures. 4. Ensuring the traceability and accuracy of analyses. 5. Guaranteeing GLP compliance by ensuring: adherence to equipment qualification and laboratory instrument calibration programs; availability of analysis supplies; training and qualification of assigned personnel; use of required quality standards; and procurement of necessary PPE for chemists to perform their duties. 6. Addressing and effectively responding to requests from departments requiring information regarding stability studies. 7. Reviewing stability study protocols and reports, as well as the analytical data supporting said reports. 8. Verifying that statistical analyses are performed on data obtained from stability studies and reviewing the resulting trends. 9. Conducting laboratory investigations and following up until closure when required by events such as CAPAs, change controls, deviations, and out-of-specification (OOS) or out-of-trend (OOT) results. Qualification and Experience Degree in Pharmaceutical Chemistry (QFB, QFI, IF, or IBI). 3–5 years of experience in the role or a similar position within the pharmaceutical industry, specifically in stability testing, analytical methods, and microbiology, as well as in Quality Control, Quality Assurance, and validation. Software: Empower, OpenLab, ChemStation; knowledge of general laboratory equipment usage. English: Conversational proficiency. Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility