Qualification : Qualification & Management of Stability ChambersStability Samples : Loading & withdrawal of Stability samples, Storage & destruction of Sample after testingReporting : Stability report compilationDocumentation & Recording : To ensure timely analysis of stability samples , Investigation of deviation, Incidents, OOS & OOT results, Storage & destruction of Sample after testing, Recording of analytical data, Preparation & Review of SOPs, Self-auditingCompliance : Adherence of SOPs, STPs & GTPS, cGMP / GLP complianceSkills Required
Root Cause Analysis, iso standards, Data Analysis, Statistical Process Control, Quality Assurance, Risk Management