● Performed cleanability studies and visible limit studies to determine the appropriate detergent and cleaning limits for new product development. ● Involved in Creating Coupon Study Protocols, Reports, and generated Cleaning Information Forms (CIF) based upon the Coupon Study. ● Conducted cleaning risk assessment on manufacturing equipment to determine difficult-to-clean surfaces and potential swab locations. ● Provide day to day support of Cleaning Validation activities in a manufacturing plant for Commercial products. ● Created manufacturing Cleaning Working Instructions, Standard Operating Procedures, Batch Records, Study Protocols and Cleaning Validation documentations. ● Created Risk based Swab Sampling Documents, Generic Cleaning Batch records for all the equipment’s. ● Worked as team member in Developing Cleaning validation matrix and as a cross functional team member for introduction and assessment of new project.

● Used Kaye Validator for temp-mapping of Incubators and Controlled temperature units for sterilization studies and good experience working with LIMS. ● Developed and executed requalification protocols to challenge existing systems and to demonstrate they continued to remain in a validated state of control, including autoclave, retain/stability chambers, incubators, freezers, refrigerators, and cold rooms. ● Wrote & executed validation protocols related to Equipment/system for manufacturing Oral Solid Dosage and Injectable Products like Lyophilize, Autoclave Sterilizer, Terminal Sterilizer, Vial Washer, Dehydrogenation Tunnel, Vial Filler, and Vial Capping Machine. ● Prepared and executed engineering studies/validation protocols and reports related to equipment (manufacturing/laboratory equipment, stability chambers & autoclaves), qualification/requalification (IQ/OQ/PQ), and test method validation. ● Worked as team member in Developing Cleaning validation matrix and as a cross functional team member for introduction and assessment of new project. ● Coordinate/communicate with the manufacturing teams about the validation/ cleaning activities. • Prepared/ Updated and executed protocols and reports for cleaning development and validation. ● Performed investigation of deviation and writing discrepancy reports in validation area processes.

● Provide technical support and trained the operators in cleaning activities. ● Actively Participated in the cleaning validation program activities to keep up with manufacturing requirements and control cleaning related failures. ● Involved in Designing and supports the implementation of new cleaning validation strategies, provides training for product transfer projects. ● Performed the Investigations and conducts troubleshooting and root cause analysis of equipment cleaning related incidents, deviations, Supported the periodic review of cleaning validation studies, CAPA and Completed Action items as assigned. ● Trained the manufacturing and QC/QA personnel on cleaning validation documentation and batch records.

● Involved and led the cleaning validation program and activities associated with the manufacturing process from inception to completion and cleaning for downstream parts, carboys, and gaskets, hoses. ● Coordinated cleaning validation activities, prepared, and executed protocols, and reports for cleaning development and validation. ● Assisted in writing the cleaning cycle development strategies for a variety of equipment including clean-in-place systems, packaging equipment, parts washers, and production facilities. ● Worked as a Floor executive for cleaning validation activities and provide technical assistance in cleaning validation activities on the floor. ● Performed Quality review, GMP, GXP, GCP. Validated PLC and HMI automation software and qualified complete process equipment systems. ● Generated associated SOPs, Preventive Maintenance procedures, and Sequence of Operations Documents. ● Performed SME assessments Track-wise for validation impact with a focus on Automation Systems including DCS - Delta V, LIMS, Lab watch Alarms, PLC skids, and automation systems.