Warning letters, 483s, Recalls, Import Alerts, Audit observations
Manage Analytical Instrumentation with cGMP Compliance, Maintenance, Qualification and Calibration
Investigation of Laboratory incidents, OOS, OOT, QMS documents, Change management, Reviewing Analytical documents
Responsible for carrying out IPQA activities, including line clearance, in-process quality monitoring, review of batch
Labware LIMS Management, QC Documents Review, Laboratory Work Allocation, QMS activites
LIMS center of Excellence for PPL sites. Supports in master data management and LIMS trouble
Shift Production operations, Batch charging, Handling Materials, SAP Entries, Documentation, DCS Operations
Development Quality, New Products and NDSRI related activities, Support in regulatory audits, dossier submission
Day to day QA activities, IPQA activities, Sampling, Line clearance activities, review of documents, batch
