Priyanka E Email & Phone Number

Lexington, Kentucky Area

• Performed Performance qualification for the Autoclave Maximum and Minimum Porous Load. • Calibrated thermocouples using Kaye Validator to perform temperature-mapping studies. • Calibrated Loggers for Heat distribution studies. • Performed Temperature mapping studies for Vessels.• Write, review and approve qualification and validation protocols and reports as well as execute protocols. Resolve protocol discrepancies and deviations.• Prepared and executed protocols and prepared final reports for IQ, OQ and/or PQ of equipment’s such as Incubators, Centrifuges, Freezers, Autoclaves, Vessels etc.• Experienced in qualifying New Lyophilizer Installation/performance/execution and validation (IQ, OQ, PQ). Written and executed protocols, reviewed and analyzed study data, written summary/final reports in order to summarize validation or revalidation/verification and commissioning activities.• Developed and executed IQ, OQ, PQ’s for Trackwise Coordinator Optimization testing, conducted testing in compliance with cGMP guidelines and FDA regulations.• Prepared Qualification Protocols for sterilization and Depyrogenation Tunnel for washed vials at set parameters. • Excel Spreadsheet Generation and Summary Report Writing for PQ studies • Reviewed and modified Standard Operating Procedures (SOPs) • Generated Discrepancy reports for errors that occurred during execution of protocol • Generated test procedures to validate new or previously unvalidated equipment/processes• Active participation to conduct Risk Assessments. • Conducted Annual Performance Qualification for the Protocols that were previously executed. • Generated Data calculation reports on Excel spreadsheet for the Run’s performed for Performance Qualification of Autoclaves and Isolators. • Worked on Qualification review on the protocols for Vial Transfer Isolators, Capper Transfer Isolators and Laboratory sterility testing Isolator.

Master Of Business Administration (Mba), Health/Health Care Administration/Management, A

Masters Degree, Masters In Pharmaceutical Sciences, A

My degreeemphasizes basic as well as applied research in drug delivery and targeting, utilizing medicinal chemistry, computational.

Bachelors, Bachelors In Pharmacy