•Lead the launch of Cell therapy site's technical review board and IT change management process, ensuring alignment with global standards, and driving initiatives aimed at improving change management process.•Orchestrated Quality oversight of commissioning, qualification/ validation processes vital for cell therapy manufacturing, technology transfer, and product launches.•Responsible for quality oversight on implementation of change request for crucial systems, including MES, DeltaV, IT infrastructure, and electronic batch record components received from network making for on-site implementation.•Supervise and led dedicated team, encompassing functions for CSV, data integrity and the qualification of equipment, and laboratory instruments.•Developed metric and identified areas of improvements within digital change process and initiated opportunities to encourage agile outputs by efficiently decreasing Turn Around Time (TAT) by improving ways of working.•Advocated for continuous improvement initiatives, cultivating an atmosphere of innovation and advancement. •Implemented significant improvements in policies, aligning them with FDA guidelines and industry best practices, thereby achieving significant milestones in elevating overall quality standards.•Participated and delegated team members, in decision-making processes to assist in Deviation investigations, identify Corrective and Preventive Actions (CAPAs), and facilitate the implementation of change controls. •Provided a nurturing and empowering atmosphere for my team's professional growth and development. This includes regular one-on-one feedback sessions, frequent performance evaluations, task delegation to foster accountability and decision-making, weekly team gatherings, cross-training initiatives, etc•Effectively assisted regulatory inspections and corporate audits, ensuring adherence to compliance standards, and streamlining the process for regulatory submissions. Provided SME output during PLI audit.

•Responsible for managing the commissioning and qualification activities on Manufacturing and laboratory facilities, equipment, and utilities using ASME 2000•Developed the procedures for the Risk Assessment and Data Integrity procedure for Equipment and Computer Systems •Provided oversight and support for ongoing GxP activities, vendor audits, as well as the creation and management of Quality Risk Management and Requalification Standard Operating Procedures (SOPs). •Implemented validation programs, and initiated data integrity gap analysis for computer system.•Effectively managed changes, including implementing process improvements, technology upgrades, and organizational changes related to validation activities.•Provided mentorship and guidance to stakeholders and strategically integrated consulting staff as required

•Led commissioning and qualification efforts on Process Control System upgrades (Honeywell to DeltaV), implementing ASTM E2500 Standard and leveraging risk-based methodologies and testing stages throughout the computer system lifecycle and ICH guidelines.•Headed the CQV effort on process, equipment, computer systems as part of the New Product Introduction process (NPI).•Supervised training schedules, coordinating vendor management and qualification processes, and ensuring the maintenance of an up-to-date and approved vendor list. •Led the design and execution of validation programs, procedures, guaranteeing adherence to GMP standards.•Drove qualification mitigation activities for the analytical equipment and computer systems to comply with identified Data Integrity gaps.•Supported the deviation investigation and decision-making processes with team members to identify appropriate Corrective and Preventive Actions (CAPAs), in the capacity of a validation representative. •Lead the CQV effort on process equipment as part of New Product introduction process (NPI). •Directed and guided a team of 5 responsible for overseeing computer system validation (CSV), data integrity, requalification efforts, and the qualification of equipment and laboratory instruments. •Effectively assisted regulatory inspections and corporate audits, ensuring adherence to compliance standards, and streamlining the process for regulatory submissions.•As CQV lead multiple capital projects, including resource allocation, timeline management, and budgeting to achieve site goals.

•Responsible for performing validation in a GMP manufacturing facility managing medium size validation projects.•Development of Validation Plans for small to medium size validation projects, qualifications and validation of cleaning processes.•Develop moderately complex protocols using risk based approach that meets current regulatory and corporate requirements and industry practices.•Responsible for presenting validation approach and study results to peers and management.•Assist validation management in overall operation of the department.•Interface with other departments regarding special projects and validation issues.•Involved in handling Deviations, inclusive of investigation, identifying root cause, impact assessment and recommending appropriate corrective and preventative actions.•Coordinate and supervise the execution and collection of testing and data reported in validation studies.•Performed Commissioning and Qualification, P&ID walk down, IOPQ for Utilities system like WFI and Clean Steam Generation.

Executed Engineering study for HVAC systems in the warehouse using wireless data loggers and generated summary report for the respective.Executed PQ for HVAC systems in the warehouse using wireless data loggers.

•Prepare and execute IQ/OQ/PQs to recertify support equipment and systems (200L Buffer Hold Bins, 200L Solution Mixer Bins, SP Column Refrigerator, 1000L Jacketed tank, SP Chromatogrpahy Skid), generating the final Report.•Execution of the Piping and Instrumentation Diagram (P&ID) walk down. •Responsible for tracking documents, progress and projections, and initial review of documents prior to formal review. •Execution of Process Development for Mixing studies on jacketed tank and Cleaning studies on SP Chromatogrphy Skid.•Participate on core team working toward validation improvements. •Responsible for training new employees and contractors, creating templates for summary reports and attachments to assist in the completion of recertification. •Prepare, revise, and review SOPs.•Perform Temperature mapping using Kaye on the SP Chromatography Column Refrigerator and Freezers.

•Generate and execute the protocols to qualify laboratory equipment (Flow Cytometer, Cell Analyzer, Multi Plate Reader, Digital Microscope, Cell Separation System) •Develop process validation plans, write protocols, execute protocols in manufacturing suites (Magnetic Bead Separator, Centrifuge, Blood Thawing Device) and author final reports for the respective.•Resolve protocol discrepancies and deviations.•Executed temperature Mapping studies for the Controlled Rate Freezers, Blood Thawing device as well as Centrifuge using Kaye Validator as well as Data loggers.

•Execute validation standards, develop testing protocols, document test results and maintain records for analysis.•Generate the summary report for the executed protocol.•Execute IOPQ, Cleaning Verification Studies, Cleaning Validations (CV) •Generate and execute the protocol for spray-ball coverage on the vessels.•Generate and execute the protocol for developing the Visual baseline of Tanks.• Handle discrepancies by identifying the root cause, assessing the risk, investigating and accordingly taking corrective action (CAPA) and assuring to prevent the error. •Collect Rinse samples as well as execute TOC along with UV-Vis swabbing for the Cleaning Verification Studies as well as the cycle development on vessels and Parts washers.•Assist in investigations and resolutions of protocol failures, filling up the gaps with the improved version.•Executed the cycle development cycles on Parts Washers.•Lead, mentor, train and act as knowledge base to individuals involved in executing the Company’s validation program as appropriate.