Nagvekar

Background

About Nagvekar

Installation & Qualification of instruments in QC Laboratory. To prepare, execute, compile and review computerized system validation protocols & documents Preventive Maintenance, Calibration, qualification & breakdown of all the QC instruments. Troubleshooting activities of all the analytical instruments within QC laboratory. Managing AMC/CMC contracts, Spares Inventory, system inventory etc. Managing internal, External Calibration of QC instruments To prepare new instrument SOPs, revise & update SOPs, Conduct trainings To review analytical data of lab support section To prepare & review schedule for internal, external calibrations and Preventive maintenance, AMC/CMC contracts. Execution and investigation of LERs, incidents, CAPA etc. in QC laboratory. To provide technical support to cross functional teams during investigation of Incidents, deviation, LER, OOS and OOT results Monitoring breakdowns, QMS and ensuring timely closure of all the records To monitor electronic data of all laboratory software, provide data for monthly reports To prepare QC for internal and external audits To ensure compliance to principles of data integrity, systems and procedures. Qualification and Validation of analysts on Analytical tests and method