Srilekha Sola

Qa Analyst @Cipla

US

Responsibilities:1. Responsible for reviewing analytical documents related to raw materials, in-process and finished products, Packaging materials, and Stability studies ensuring timely release upon compliance verification.2. Responsible for reviewing and ensuring compliance related to qualifications and calibrations of laboratory equipment. Responsible for maintaining the laboratory instrument qualification and calibration documents which includes schedules (calibration and preventive maintenance) and ensuring their compliances.4. Responsible for reviewing, ensuring compliance of method validation, verification, and transfer protocols and reports.5. Responsible for ensuring continuous compliance with current Good Laboratory Practices (cGLP) through ongoing monitoring.6. Responsible for reviewing process validation and characterization protocols for compliance and accuracy.7. Responsible for maintaining the tracking of all material related documents and trend data.8. Responsible for reviewing data and ensure compliance pertaining to laboratory investigations (OOS, OOT and Non-Conformances).9. Responsible for proper archiving of incoming documents and ensuring accurate issuance and documentation practices.10. Expected to demonstrate flexibility in work hours and responsibilities to meet business needs.