Description:The Laboratory Information Management System (LIMS) Administrator provides administrative and developmental support to the LIMS project within the QC department. The person will be responsible for handling and leading entire Caliber LIMS Activities of Amneal Pharmaceuticals. The LIMS Administrator's act as SMEs (Subject Matter Experts) and as such are expected to help with troubleshooting of the live system as and when issues arise. The position requires to be compliant with site systems and regulatory requirements working to cGMP. This role requires that the individual is technically minded and personal qualities such as attention to detail and has good communication skills. He/she will be required to learn how to build and configure the LIMS system and to manage user accounts. The role requires organization and planning skills with the ability to explain and train in a succinct manner. The individual is required to manage any events and/or deviations relating to any LIMS activities and that they are closed to the set due date.Essential Functions:
Preparation & Review of configured Test plan, COA and compiled COA. Responsible to follow and maintain the cGMP and GLP. Ensure to follow the safety norms and adhere to company policy.
Timely providing the LIMS masters for routine Analytical usage in Laboratory. Preparation of LIMS related protocol study and execution. Review the change controls and any other revisions related to LIMS and maintain the laboratory records.
Preparation and review of LIMS relevant SOPs, procedures, testing plannings, etc.
LIMS master preparation for various product/material/instruments/Volumetric solutions etc.
Registration of reference standard, working standard, column, instrument etc. in LIMS.
Timely conducting training on LIMS Related updates & also training of Laboratory personnel as when required.
Responsible to follow and maintain the cGMP and GLP. Ensure to follow the safety norms and adhere to company policy. Preparation/revision/review of instrument calibration schedule in LIMS.
Review the change controls and any other revisions related to LIMS and maintain the laboratory records.
Preparation/revision/review of instrument calibration schedule in LIMS.
Any troubleshooting in LIMS.
Involvement in Qualification of LIMS module/Instrument.