1. Preparation of an annual stability program in compliance with NOM-073-SSA1-2015.
- 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.
- Verification that the maintenance, qualification, and use of in-house climatic chambers align with established programs and procedures.
- Ensuring the traceability and accuracy of analyses.
- 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.
- Addressing and effectively responding to requests from departments requiring information regarding stability studies.
- Reviewing stability study protocols and reports, as well as the analytical data supporting said reports.
- Verifying that statistical analyses are performed on data obtained from stability studies and reviewing the resulting trends.
- 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.