Jawahar K

1. Methodically gathered precise clinical trial data from sites, analyzed issues, and ensured timely resolution. 2. Maintained effective communication with sites, CRAs, project managers, and sponsors to expedite issue resolution. 3. Coordinated with investigator sites on Specimen Pending Arrival Reports, requested shipping updates, and tracked resolution of delivery/storage issues. 4. Updated central database with accurate sample data to support communication between clinical sites and data review teams, ensuring patient safety. 5. Assisted Data Management team with database reconciliation and data lock activities. 6. Acted as backup for Data Manager; participated in client meetings to discuss DMP, resolve data discrepancies, and provide project updates. 7. Managed queries efficiently to resolve discrepancies and enhance data quality. 8. Supported development and continuous improvement of clinical operations escalation protocols. 9. Introduced innovative escalation strategies and problem-solving methods in clinical trials. 10. Performed quality control on released discrepancy holds, maintaining thorough documentation to ensure data integrity. 11. Handled CAPA, QMS, and quality events, including investigation, documentation, and corrective actions. 12. Reviewed SOPs, study protocols, and escalation processes to enhance workflow. 13. Mentored site coordinators and addressed process-related queries. 14. Allocated workload, created daily task plans, and generated TAT reports to optimize team performance. 15. Well-versed in ICH-GCP guidelines, regulatory audit readiness, LabCorp SOPs, and tracking systems. 16. Proficient in software tools: Zavacor, Gopher, Contact Center, Veeva Vault, XIP, Power BI, and MS Office Suite.

1. To perform water sampling and water analysis and final releasing and review of all documents 2.To monitor GLP activities in Lab area 3. Water trend preapation and documents, protocol perapation using excel, word, power point 4.To perform vitek 2 compact system 5. Handling of ELMS, EDMS, BIOVIA Software

1. Inoculation preparation. 2. Ph and OD value check 3. In process sampling activity

I am experience in enzymatic assay, sterility, tvc and tsc cout as per CFU, culture media preparation, culture maintain, pure culture isolation, FG sample analysis, raw material analysis like pathogen test, fermentation inprocess sample analysis, qa work like COA preparation, audit documents, knowledge about HACCP, VACCP, TACCP, ISO 22000, FAMI QS

I am work in the food microbiology department and experience in the various company product like juice, seeds, water, oil etc.

Learning and handling pipette and centrifuge techniques