Jaykumar Mishra
Bangalore
Summary
Performance-driven CSV QA specialist with 8+ years of expertise in ensuring compliance with GAMP 5 guidelines, ICH Q9, EU Annex 11 and 21 CFR Part 11 regulatory requirements. Proven track record in CSV Project Management, QMS Management, and QA review of CSV documents. I am skilled in Agile methodologies, Six Sigma, ISPE GAMP 5 Compliance, and Cloud Systems Validation. Adept at leading teams and driving business results through effective change management and strategic consulting. Strong communicator with a passion for applying agile ways of working. Committed to interfacing and consulting on business processes to achieve optimal outcomes. Recognized for sound overall business judgment and a results-oriented approach.
Overview
9
9
years of professional experience
1
1
Certification
Work History
IT Consultant (CSV IT)
Xellia India Private Limited
Bengaluru
10.2025 - Current
- Implemented NIS-2 directive for cyber security compliance, strengthening organizational security posture.
- IT Security related Activity, maintaining Risk Register, Security vulnerability Management
- Developed IT SOPs and secured approval to ensure compliance and operational efficiency.
- Software Validation documents review and approvals.
- Management of IT GxP documents in MyProcess tool.
- Change Management in Trackwise
- Managed CAPA processes in Trackwise to address non-conformities and enhance quality assurance.
- Internal & External Audit handling and compliance
- AI tools implementation and validation
- CSV inventory management
Advisor Computer Systems QA (CSQA)
GSK Global Capability Center
Bengaluru
01.2024 - Current
- Lead and manage all validation projects and activities for the development and release of products, in accordance with CSV and regulatory requirements.
- Reviewed and approved GxP assessments, Validation Plans, and entire Validation Life Cycle documentation to ensure compliance and quality standards.
- Provides input, reviews and approves quality records related to CSV including Deviation, Change Controls and CAPAs.
- Conducted risk assessments to identify validation gaps and proposed mitigation strategies to enhance compliance and reduce potential risks.
- Ensure supported systems are validated in compliance with applicable policies and procedures.
- Participate in self-inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately understood.
- Define and maintain a global Computer System Validation (CSV) methodology and policies/procedures in accordance with current regulatory guidelines.
- Provide appropriate training and guidance to employees and strategic partners on CSV procedures and policies.
- Execute effective process and procedures in CSQA & GQA and contribute to business processes and procedures outside GQA.
- Supported routine computer compliance vendor audits (internal & external) and contributed to computer compliance initiatives.
- Identified and mitigated computer-related business or reputational risks, communicating findings and risk management solutions to stakeholders.
Software Quality Assurance Specialist I
Qinecsa Solutions Pvt. Ltd.
Mysore
09.2022 - 10.2023
- Lead the planning, execution, and delivery of Computer System validation activities.
- Ensure all systems are validated according to GxP requirements, internal SOPs and applicable regulatory guidelines.
- Preparation, execution and reporting of GxP computerized systems validation deliverables at site.
- Ensure all validation activities adhere to regulatory requirements and company standards.
- Managed change control processes, periodic reviews, and system retirements to uphold compliance standards.
- Conducted periodic reviews of all GxP computerized systems to ensure ongoing compliance with regulatory requirements.
- Coordinated with system vendors to deliver validation documentation and maintain vendor qualifications.
- Maintain the validated state of all GxP computerized systems used at the site.
- Oversee end-to-end implementation of assigned projects, including tracking progress, following up on tasks, and managing escalations.
- Ensure self-inspection and remediation activities related to GxP computerized systems.
- Provide inputs for the revision and implementation of Computerized System Validation (CSV) procedures.
- Manage associated QMS activities to ensure timely completion of action items, including Change Controls, Deviations, investigations, and CAPAs.
- Review protocols, QMS documents, CSV deliverables, and other related documents to ensure accuracy and compliance.
- Ensure the site is prepared for all audits and actively participate during audit processes.
- Maintain an updated inventory of GxP computerized systems.
- Ensure that Annual Computerized System Validation Master Plan and Reports are managed as per annual schedules.
VALIDATION EXECUTIVE
Lupin Limited. (Contract Role ICS India Ltd.)
Tarapur
08.2020 - 09.2022
- Authoring Computer System Validation deliverables like GxP Assessment, Validation Plan (VP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Functional Risk Assessment (FRA) using FMEA, Design Specifications (DS), IQ/OQ/PQ protocols, Validation Summary Report (VSR).
- Coordinated with stakeholders to align project objectives with company goals and optimize resource allocation.
- Handled Team size of 12 head count at Site to Complete CSV activities of GxP computerized Systems at PDLAB, R&D, Manufacturing and QC facility of Lupin Tarapur.
- Identify opportunities for process improvements in the CSV lifecycle and implement best practices to enhance validation efficiency and effectiveness.
- Developed strategies that streamlined executive processes, improving operational efficiency.
- Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement.
- Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner.
- Coordinated with stakeholders to align project objectives with company goals and resources.
- Facilitated communication between departments to ensure alignment on project progress and challenges.
- Conducted risk assessments to identify potential issues in project execution and delivery timelines.
- Developed and implemented strategies to increase executive efficiency.
- Coordinated cross-functional teams to deliver high quality results within tight timelines.
- Organized and facilitated regular meetings with senior management teams.
- Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment.
IT Executive (CSV Lead)
Lupin Limited.
Tarapur
08.2020 - 09.2022
- Leads the effort to manage and maintain validation of the GxP computerized systems.
- Third party CSV team handling and driving QC and Manufacturing units CSV Projects to ensure GAMP 5, 21 CFR Part 11 regulation, EU Annexure 11, ICH Q7, Q9 and PIC/S guidelines compliance requirements.
- Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQs, TRM.
- Develop and maintain validation documentation including validation plans, risk assessments, URS, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
- Trained and guided system and project stakeholders on computer systems validation best practices, risk management, and industry guidance to enhance compliance and operational effectiveness.
- Advised on IT project execution and infrastructure operations, focusing on risk and compliance to ensure alignment with regulatory standards.
- Provides IT audit support for internal and external audit entities (e.g., TGA, FDA, MHRA) regarding standards and practices.
- Supported software supplier assessments to evaluate engagement suitability for IT systems and processes within manufacturing and quality operations.
- QMS handling related to CSV which includes Change control handling, CAPA, Deviation initiation and closure.
- Contributed to IT applications project management initiatives, focusing on validation activities following the GAMP life cycle approach.
VALIDATION ENGINEER
Sarla Advantech Pvt. Ltd.
Mumbai
12.2018 - 05.2020
- Created, reviewed, and executed validation protocols for computer systems, ensuring thorough assessment of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Ensure all validation activities comply with relevant regulatory requirements (e.g., FDA, EMA, GxP, 21 CFR Part 11), industry standards, and company policies.
- Maintain detailed and organized validation documentation, including validation plans, protocols, reports, and traceability matrices.
- Participate in risk assessments to identify and mitigate risks associated with computer systems.
- Managed and documented changes to validated systems, maintaining compliance and integrity throughout system lifecycle.
- Work closely with IT, Quality Assurance, Manufacturing, and other departments to ensure successful validation of computer systems.
- Prepare for and participate in internal and external audits, providing necessary documentation and responses to audit findings.
JR. VALIDATION ENGINEER
QA Tech
Mumbai
08.2017 - 12.2018
- Developed validation plans detailing scope, strategy, objectives, resources, and timelines for projects, aligning with regulatory requirements and project goals.
- Developed, reviewed, and executed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols to verify that computer systems met intended use and performance criteria.
- Created and maintained a Traceability Matrix (TRM) to ensure all requirements were met and traceable throughout the validation lifecycle, providing clear documentation of the relationships between requirements, test cases, and results.
- Authored Validation Summary Reports (VSR) documenting validation process, findings, and conclusions, providing overview of activities and ensuring regulatory compliance.
- Conducted GxP assessments to determine the regulatory impact of computer systems and prepared User Requirements Specifications (URS) and Functional Requirements Specifications (FRS) to ensure compliance with regulatory standards and client needs.
- Developed and managed system retirement plans and documentation, ensuring that decommissioned systems were properly validated and that all compliance requirements were met during system retirement.
- Executed tasks supporting project operations, completing all responsibilities on time.
Education
Post-Graduation Diploma - Industrial Automation
01-2017
Bachelor of Engineering - Instrumentation Engineering
Gondwana University
06-2016
Higher Secondary School Certificate -
Nagpur, Maharashtra State Board
06-2011
Skills
- CSV Project Management
- QMS Management
- Quality Risk Management
- QA review of CSV Documents
- Agile and Six Sigma
- ISPE GSMP 5 Compliance
- 21 CFR Part 11 Compliance
- Cloud Systems Validation
- Change Management
- Vulnerability Management
- Audit review and compliance
- Stakeholder Management
- Cybersecurity compliance
- Process improvement
- IT compliance
Certification
- Agile Scrum Master Certification, Simplilearn, 2022
- Six Sigma Yellow Belt, 2022
- Agile PMP Certification, 2022
- Vulnerability Management Certification, Udemy, 2026
Accomplishments
- Ownership for Result Award, Sarla Technologies, 2020.
- CSV Project Completion Award for C-DAS Project, Lupin Limited, 2022.
- CSV Project Completion Award for Biometric Project, Lupin Limited, 2022.
Disclaimer
I, hereby acknowledge that all particulars and details mentioned above are accurate and true to my knowledge.
Timeline
IT Consultant (CSV IT)
Xellia India Private Limited
10.2025 - Current
Advisor Computer Systems QA (CSQA)
GSK Global Capability Center
01.2024 - Current
Software Quality Assurance Specialist I
Qinecsa Solutions Pvt. Ltd.
09.2022 - 10.2023
VALIDATION EXECUTIVE
Lupin Limited. (Contract Role ICS India Ltd.)
08.2020 - 09.2022
IT Executive (CSV Lead)
Lupin Limited.
08.2020 - 09.2022
VALIDATION ENGINEER
Sarla Advantech Pvt. Ltd.
12.2018 - 05.2020
JR. VALIDATION ENGINEER
QA Tech
08.2017 - 12.2018
Post-Graduation Diploma - Industrial Automation
Bachelor of Engineering - Instrumentation Engineering
Gondwana University
Higher Secondary School Certificate -
Nagpur, Maharashtra State Board