RAJESWARI S
Bengaluru,KA
Summary
Results-driven QAQC Executive with expertise at Syngene International, specializing in analytical method validation and regulatory compliance. Proficient in HPLC and LIMS, I excel in root cause analysis and CAPA implementation, ensuring high-quality standards. Adept at managing audits and fostering team collaboration to enhance laboratory efficiency and data integrity.
Overview
4
4
years of professional experience
Work History
QAQC Executive
Syngene International
02.2021 - Current
- Conduct reviews of analytical data and validation reports for analytical methods.
- Ensure adherence to SOPs, GMP standards, and regulatory guidelines.
- Develop and execute protocols for analytical method validation and verification, along with comprehensive report documentation.
- Manage investigations related to laboratory incidents and deviations Support the investigation of OOS and OOT results, perform root cause analysis, and implement corrective and preventive actions (CAPA).
- Execute instrument qualification for SCA, VP, URS, FS, IP, OP, and QP systems.
- Prepare for regulatory audits, including those from USFDA, Health Canada, and client audits.
- Oversee laboratory data management through LIMS and document activities using Electronic Lab Notebooks (ELN).
Education
Master of Science - General Chemistry
MGR Arts And Science
Hosur01-2020
Skills
- Handling of HPLC-Agilent, Shimadzu
- Handling of KF Autotitrator - Metrohm
- Handling of IR Spectrophotometer - Perklin Elmer and UATR
- Handling of UV Spectrophotometer - Agilent carryvin UV 60
- Handling of PH Meter - Mettler Toledo
- Handling of Dissolution Apparatus - Electro lab & lab India
Languages
English
Tamil
Telugu
Kannada
Additional Information
- LIMS
- EDMS
- Trackwise
- Chromeleon
- Tiamo
- MS office
Declaration
I hereby declare that the above-mentioned details are true to the best of my knowledge and belief.
Yours faithfully
(Rajeswari S)
Place: Bengaluru
Timeline
QAQC Executive
Syngene International
02.2021 - Current
Master of Science - General Chemistry
MGR Arts And Science
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