Responsible for planning of LIMS team & review of specification /methods & test plan in laboratory information management system.
Review of finished products, validation batch and intermediate samples received in QC Laboratory.
Manage source planning, monitoring and control of manpower, instrument usage, facilities, spares and maintenance of instrument , HPLC, GC lab to accomplish work requirement.
Planning and work allotment / Finish product for officers / Executives and Sr. Executives for samples testing and review . Ensure timely release of in process and intermediate samples, so as to make the available for manufacturing / release of drug product.
Conduct lab investigation of OOS, OOT , laboratory incidences and deviations . Initiate Change controls and implement the proposed actions.
Provide troubleshooting support to analyst in the lab.
Support best practices in laboratory in terms of integrity , accuracy and adequacy of the testing and documentation.
Provide training on revised SOPs to analyst in the lab.
Ensure cGMP complaince in the laboratory during sample testing.
Ensure timely testing , review and release of all test samples as per approved specifications , STP and customer requirements.
Coordinate technology transfer during new product launches and coordinate with other departments for audit and compliance .