Grupo PiSA is looking for a Quality Stability Chemist to generate and fulfill the Annual Stability Program, integrating regulatory requirements for delivery to Regulatory Affairs. In this role, you will ensure compliance with Official Standards, Pharmacopoeias, and applicable ICH guidelines to support our mission of making life a healthy story.

What You'll Do

Generate the annual Stability Studies Program.
Prepare stability protocols and reports according to the Annual Stability Program, Product Annual Review, expiration date confirmations, and new product launches.
Perform identification, installation, monitoring, withdrawal, and control of product samples in stability studies.
Update the inventory of products in stability chambers, chromatographic columns, glassware, and reference standards.

What We're Looking For

Bachelor's degree in QFB, QFI, QBP, LF or a related field in the Pharmaceutical Industry.
Professional license (Cédula Profesional).
1 to 3 years of experience as a stability chemist or analytical support chemist within the pharmaceutical industry.
Experience with compliance to Pharmacopoeias and the elaboration of operating procedures.
Experience using Quality Management Systems such as SAP, TrackWise, and/or LIMS.
Knowledge of national and international standards (e.g., NOM059, NOM073, ICH, CFR) for drug manufacturing and stability studies.
Knowledge of quality systems and hygiene and safety in the analytical laboratory.