Aug 2023 – Dec 2024 · 1 yr 4 mos · Hyderabad, Telangana, India · Hybrid

• ✓ As Global Testing and Validation Lead for Syncade EMES System, support global users to ensure lean implementation and continues improvement of the Testing and CSV Standards for Syncade EMES system.
• ✓ Define test strategies and roadmaps and drive continuous testing and innovation to achieve acceleration and quality meeting business objectives.
• ✓ Provide technical expertise in Testing Methodologies, Testing Processes, Test Automation, Tools and Techniques across the teams.
• ✓ Work with Developers and the Domain Leads to develop and execute QA strategies to meet and exceed department and functions quality goals.
• ✓ Build and maintain strong relationships with stakeholders and facilitate effective communication and collaboration across cross-functional teams.
• ✓ Identify, establish, and improve processes to increase team efficiency and execution across sprinting, backlog grooming, launch management, and demos.
• ✓ Responsible for the establishment of centralized testing and validation service and developing the appropriate organizational structure, resource plans and culture to support the business objectives.
• ✓ Lead the Testing and Validation team in preparation for regulatory, internal and corporate audits and inspections.

Apr 2022 – Jul 2023 · 1 yr 3 mos · Remote

• ✓ Lead the compliance team in Validation and compliance projects
• ✓ Performed End-to-End Computer System Validation activities in according with GAMP 5
• methodology.
• ✓ Provide Quality Management Support during SDLC activities.
• ✓ Perform Gap Assessment to determine the system is GxP or Non-GxP.
• ✓ Perform review and approval of the validation deliverables (VP, IQ, OQ, UAT protocol
• including test cases, report, RTM and validation summary report, etc.) In EDMS and provide
• validation proceed input to the team.
• ✓ Responsible for Change Control, Deviation and CAPA management process.

Dec 2021 – Apr 2022 · 4 mos · Bangalore Urban, Karnataka, India

• ✓ Leading quality and compliance projects in regulatory compliance.
• ✓ Responsible for Computerized system validation concept such as GAMP 5 – A risk-based
• approach to compliant GxP computerized systems.
• ✓ Hands on experience of preparing validation deliverables for software implementation projects.
• ✓ Actively contribute to the IT application project management that includes validation activities
• as per GAMP life cycle approach.
• ✓ Perform gap assessment and remediation procedures for legacy applications to ensure
• validation policies is in line with life cycle approach.
• ✓ Perform software classification, IT risk assessment and mitigation strategies for IT
• applications.
• ✓ Proficient in SOP documentation, drafting work instructions / user manuals, authoring and
• review of validation deliverables such as validation plan & report, requirement specification,
• risk analysis, qualification protocol and report, test script, traceability matrix, etc.
• ✓ Proficient in quality system elements such as Deviation, Root Cause Analysis, CAPA and
• Change control etc.
• ✓ Good exposure to incident management, change management, periodic review, vendor
• management, quality management review procedures and internal audits.

May 2020 – Dec 2021 · 1 yr 7 mos · Bengaluru, Karnataka, India

• ✓ Lead project compliance work stream and responsible for end-to-end quality & compliance aspect of the project and validation activities.
• ✓ Responsible for key validation work, provide GxP related validation expertise and partners with the key stack holders in defining in the validation strategies.
• ✓ Responsible for document management process i.e., review, update and approve work including RMR, QRA, AIA, validation plan, test plan, qualification script (IQ, OQ, PQ), test protocol and report, Tracebility matrix and validation summary report.
• ✓ Contribute to the improvement of technical and scientific calibration & qualification methods
• through identification of means to optimize experimental process.
• ✓ Responsible for Medical Device Lab related elements like calibration, equipment maintenance, Qualification, SOP preparation, Laboratory environmental monitoring, risk management etc.
• ✓ Execute, measure and report on the progress of the Quality management strategic initiatives
• related to Metrology and Qualification.
• ✓ Support for continuous improvement of process through detailed failure analysis for
• nonconformance and investigate, develops and implement effective and compliance solutions
• for process corrections and effectively implement CAPA.
• ✓ Develop and implement the Quality management strategy in collaboration with Baxter quality leadership, referring the global Quality documents and regulatory requirements.
• ✓ Lead the development, sustenance and continuous improvement of quality system complying with 21 CFR 820, ISO 13485 and ISO 17025 quality system requirement with a specific focus on Metrology, qualification and Lab QMS activities.
• ✓ Co-ordination with the device quality team and ensure maintaining GxP standards and actively
• participate in the Audit process including types of audits, planning, preparation, execution, reporting results and follow up.
• ✓ Engage in continuous improvement activities by identifying opportunities and improvements

Mar 2019 – May 2020 · 1 yr 2 mos · Bangalore

•  Design and execute Quality engineering related protocol and summarize study to ensure consistency of data to compliance with manufacture and customer specifications with cGMP.
•  Execute re-validation, area / equipment qualification, Instrument Calibration, risk assessment and design deliverables as per the planner and when the facility undergoes changes.
•  Responsible in identifying root cause and coordinate corrective action to quality issue in the facility.
•  Drive operational excellence and improvement project related to activities.
•  Assisting in creating process documentation to ensure production processing consistent within validated parameters.
•  Acts as technical liaison as needed between engineering and quality team.
•  Monitor event trends in order to provide proactive corrections/improvement alternatives to minimize the potential for repeat incidents.
•  Responsible for the design, schedule, execution, and evaluation of scientifically and statistically sound qualification experiments which define and demonstrate that critical Controls, Equipment, Facilities, Processes and Utilities function in a consistent and repeatable manner, and are in compliance with regulatory requirements, product license restrictions, and policies affecting final product integrity.
•  Review of calibration, validation and qualification documents & maintain the data and archiving as per procedure.
•  Preparation of operational SOP with reference to guidelines, national and international standards.
•  Coordinate with Technical service team to understand the process requirement and clarification on technical specification for modification and new projects.
•  Responsible for reliability of overall instrumentation and control system.
•  Handling overall project from design, selection, installation, commissioning and handover of equipments to the user department.
•  Review of P&ID for the equipments related to project and approves the same.

Sep 2017 – Feb 2019 · 1 yr 5 mos · satghyamangalam

• 1. Established Calibration Laboratory with electro technical, thermal and mechanical parameters at college.
• 2. Established ISO 17025 accreditation for the calibration laboratory.
• 3. Preparation of Quality manual, SOP’s, uncertainty budget and all other documents and formats as per ISO 17025.
• 4. Purchase of instruments and reference standards.
• 5. Frame the scope and CMC for the calibration laboratory.
• 6. Planning and execution of calibration and maintenance activities of various instruments.
• 7. Prepare and maintain all the documents related to calibration.
• 8. Internal audit, root cause analysis, implementation of corrective and preventive actions (CAPA).
• 9. Training students and faculty members in calibration process.
• 10. Incharge sensors and instrumentation laboratory.
• 11. Skill development coordinator.
• 12. Department Internship Coordinator.
• 13. Coordinator for IEEE student chapter.
• 14. Handling Classes for UG and PG students.

May 2017 – Aug 2017 · 3 mos

• 1. Execute/Supervise with the help of contractors on daily basis for follow up and completion of calibration, thermal mapping, other engineering cGMP documentation activities and projects.
• 2. Execute/Supervise the engineering department online documentation all time with respect to calibration and thermal mapping.
• 3. Prepare master calibration schedule, update calibration records, calibration reports review and archival.
• 4. Execute/Coordinate/maintain quality in upcoming engineering projects in line with the cGMP and organization requirements.
• 5. Verify and ensure that calibrations are performed as per procedure.

Nov 2016 – May 2017 · 6 mos

• 1. Execute/Supervise with the help of contractors on daily basis for follow up and completion of calibration, thermal mapping, other engineering cGMP documentation activities and projects.
• 2. Execute/Supervise the engineering department online documentation all time with respect to calibration and thermal mapping.
• 3. Prepare master calibration schedule, update calibration records, calibration reports review and archival.
• 4. Execute/Coordinate/maintain quality in upcoming engineering projects in line with the cGMP and organization requirements.
• 5. Verify and ensure that calibrations are performed as per procedure.

Jan 2014 – Aug 2015 · 1 yr 7 mos · India · Hybrid

• Supported multiple MSME Manufacturing industries to setup Internal Calibration Laboratories with reference to ISO 17025.
• Support the Calibration, Validation and thermal mapping for pharmaceutical and Manufacturing Industries.

Dec 2012 – Dec 2013 · 1 yr · Bangalore

• 1. Responsible for the planning and execution of calibration and maintenance activities of various instruments.
• 2. Performs calibration of all field Instruments. Also for other instruments that needs Calibration as instructed by the Technical Manager.
• 3. Prepares all reference standards to be used in performing calibration as well as all necessary documents before and after calibration.
• 4. Conduct intermediate checks and preventive maintenance monitoring to ensure the accuracy and functionality of all reference standards.