Shashikumar Gn Email and Phone Number

6+ years of experience in Quality assurance (API).QMS:1. Handling of Deviation and CAPA in Trackwise software and involving in the investigation and identification of root cause.2. Trending of deviation and CAPA through Trackwise software.3. Conducting the quality management escalation meeting as per procedure.4. Preparation, Review of risk assessment documents for deviation, new product, equipment &system.5. Handling of OOS / OOT and involving in the investigations. 6. Handling of change control and evaluating the impact of the change.IPQA:1. Responsible for issue control, retrieval and archival of documents & records in line with QMS requirements.2. Responsible for Reviewing of Master BMR and Executed BMR.3. Responsible for Product inspection and container sealing.4. Responsible for APQR, Batch record review – Analytical report review.5. Responsible for Line clearance – visual inspection, container verification, QA approval.6. Responsible for BMR – Issue, retrieval and review.7. Responsible for handling Sales-Dispatch activities (Data logger), Transport.8. Responsible for Routine Plant inspection to ensure the GMP compliance.9.Worked as an active participant in USFDA and various other customer audits.11. Knowledge about handling of deviation & Customer complaint.12. To operate various software systems like SAP, Cipdox, Trackwise, LIMS etc. based on the roles and rights provided in the Software