Stability Officer
Core
Execute stability studies for pharmaceutical products across global markets, investigate deviations and out-of-trend results, and ensure product shelf-life compliance.
Role type
Stability Officer (Quality Systems)
Builds
Stability data and reports supporting regulatory submissions and product lifecycle management
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
stability study design, deviation investigation, statistical evaluation, protocol writing, regulatory compliance knowledge, data analysis, change impact assessment, climate chamber monitoring
Preferred skills
cGMP regulations, analytical and microbiological testing knowledge
Technologies
LIMS, climate chambers, statistical software
Responsibilities
Coordinate and plan new and ongoing stability studies; prepare stability protocols; evaluate results and escalate deviations; write statistical evaluations for product reviews; advise on the impact of formulation or packaging changes; handle data requests from regulatory teams; monitor climate chamber operations; propose process optimizations; stay updated on stability study requirements.