Job Description

Perform and/or oversee duties as needed as related to stability sample management which include, but is not limited to, receipt, verification of samples, labelling of samples, documenting & maintaining inventory, staging samples for storage in stability chambers, placing stability samples in the stability chambers, pulling samples through stability software, delivery to testing labs, identification of on-demand/terminated stability samples for destruction. Document data accurately and maintain neat/ concise/ organized stability records. Ensure stability chambers are maintained appropriately through scheduled calibration, preventive maintenance/repair and validation. Initiate stability samples along with description test. Analyze Exhibit samples/Validation, Method Transfer, Swab samples allotted for testing using HPLC, GC, UV instruments, etc. as per Stability Protocols and standard test procedures Ensure standardization of working standards and conduct calibration of laboratory instruments. Document analytical data and calculate results. Enter analytical data in Stability Software and generate Stability Reports. Ensure compliance to cGMP requirements and laboratory procedures. Submit samples for destruction after completion of analysis. Ensure integrity, accuracy and adequacy of the analysis performed. Compliance of electronic systems like DCM and LMS in the laboratory.