lims developer

1 week ago


Pune, Maharashtra, India CIEL HR Services Full time
Role - LIMS DeveloperExperience - 7+ yearsLocation - Bangalore (Preferred)Skills - LIMS , EMPOWERMENT CDS , 21CFR Part 11 and GxP , SOPs


Roles and ResponsibilitiesStrong Technical Knowledge on Empower3 FR5 & other CDS SystemsMaintaining and supporting current CDS systemEnd user issue support, troubleshooting, & resolutionAdministration of CDS system and server maintenanceBackup, archival, restore and periodic review of systemLACE supportProject Management / ArchivalEnsures and maintains security and appropriate controls.

Evaluates policies procedures and standards for quality systems.
Proposes and participates in the implementation of enhancements that improve systems and provide enhanced compliance.

Support in deployment/Installation of CDS applicationsComplete knowledge on user management of lab applicationsCoordinate with multiple instrument vendor during application/instrument setup and instrument qualificationHand-holds Site SME's in Empower operations and implementations through proper training and supportExperience working in a Pharmaceuticals, Chemical, Manufacturing or any regulated environment....

Excellent verbal and written communications skillsValidation of all laboratory and instrument software including maintenance of the Master Validation Plan, functional requirements, risk assessment, and execution of validation protocolsData integrity and compliance to 21CFR Part 11 and GxP standardsPrepare draft and final SOPs and compliance documents
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