Sucharitha K Email & Phone Number

Boston, Massachusetts, United States

• Authored of Validation Lifecycle documents such as the Validation Master Plan, Computer System Validation Master Plan, User Requirement Specifications, Factory Acceptance Tests, Site Acceptance Tests, Installation Qualifications, Operational Qualifications, Performance Qualifications, and Process Validation protocols, as well as change controls, risk assessments, component criticality assessments and the traceability matrix.• Experience in validating HPLC systems for pharmaceutical and… Show more • Authored of Validation Lifecycle documents such as the Validation Master Plan, Computer System Validation Master Plan, User Requirement Specifications, Factory Acceptance Tests, Site Acceptance Tests, Installation Qualifications, Operational Qualifications, Performance Qualifications, and Process Validation protocols, as well as change controls, risk assessments, component criticality assessments and the traceability matrix.• Experience in validating HPLC systems for pharmaceutical and analytical laboratories. Proficient in developing and executing validation protocols, including method validation, system suitability testing, and performance qualification.• Developed critical validation lifecycle documentation to support the qualification/validation of equipment, utilities, and facilities (IQ, OQ and PQ protocols, Operational SOPs, PM SOPs, Change Controls, User/Functional/Design Specifications) Show less

Foster City, California, United States

At Gilead Sciences, I honed my skills in ensuring adherence to Good Manufacturing Practice (GMP) standards, contributing to PLC programming and SCADA/HMI systems integration. I also have hands-on experience in temperature mapping studies, monitoring aseptic fill lines, depyrogenation tunnels, Autoclaves Where I had done the Empty chamber and maximum load studies using kaye validators and terminal steam sterilizers, and also implementing robust monitoring and testing protocols to uphold quality… Show more At Gilead Sciences, I honed my skills in ensuring adherence to Good Manufacturing Practice (GMP) standards, contributing to PLC programming and SCADA/HMI systems integration. I also have hands-on experience in temperature mapping studies, monitoring aseptic fill lines, depyrogenation tunnels, Autoclaves Where I had done the Empty chamber and maximum load studies using kaye validators and terminal steam sterilizers, and also implementing robust monitoring and testing protocols to uphold quality standards. Show less

Plymouth, Minnesota, United States

• Developed and executed IQ, OQ, PQ documents, UAT, FAT, SOPs, and Engineering Change Requests for HVAC systems, water systems and Autoclaves.• Implemented 21 CFR Part 11 for new and existing testing computerized laboratory instruments, performed gap assessments and defined resolutions in compliance with cGMP requirements.• Reviewed Risk Assessment Documentation to check the areas with deficiency, reviewed Corrective and Preventive Action (CAPA), STAT testing and drafting Remediation… Show more • Developed and executed IQ, OQ, PQ documents, UAT, FAT, SOPs, and Engineering Change Requests for HVAC systems, water systems and Autoclaves.• Implemented 21 CFR Part 11 for new and existing testing computerized laboratory instruments, performed gap assessments and defined resolutions in compliance with cGMP requirements.• Reviewed Risk Assessment Documentation to check the areas with deficiency, reviewed Corrective and Preventive Action (CAPA), STAT testing and drafting Remediation Plans for the project management approval after the GAP Analysis.• Developed detailed Project Plan, reviewed User Requirement Specifications (URS) and Functional Requirements Specifications (FRS).• Authored and executed qualification protocols for manufacturing and laboratory equipment including chromatography (HPLC & GC), Autoclave, Freezers, Spectrometer and Microscopes. Show less

Karnataka, India