AKSHAT SRIVASTAVA — Associate Consultant

I am a dynamic, team-spirited, and results-oriented leader with over 14 years of experience in Computer System Validation (CSV), Quality Assurance, Security & Compliance, and Risk Management. As a Validation Manager and Test Lead/Manager, I have successfully led and delivered major projects for leading European pharmaceutical companies, managing 500+ change controls and 100+ releases for GxP & Non GxP systems. I have worked across different domains and various types of applications like Clinical Trials Management Systems, RAVE EDC, RAVE Architect, Standards and Management Systems, Clinical Data Warehouses, Patient Support Systems(Salesforce), Serialisation Systems - ATTP & UDI. My cross-functional team leadership roles include: - Defining end-to-end validation strategies for large, business-critical programs and IT systems, collaborating with diverse teams across departments. This resulted in a 30% reduction in validation cycle time and improved compliance. - Coordinating with Business & IT stakeholders to perform and review Functional Risk Assessments, Vendor Assessments, and Backup and Recovery Assessments. This collaboration ensured seamless integration and compliance, reducing risk by 25%. - Leading internal audits to ensure compliance with Client SOPs and regulatory requirements, working closely with quality, compliance, and technical teams. These audits led to a 15% improvement in audit readiness and compliance scores. - Managing and mentoring cross-functional teams to execute projects and review Plans & Reports(e.g. Migration Plan & Report). This effort resulted in successful project deliveries with zero non compliances and enhancement in team productivity. - Conducting Periodic Reviews of GxP & Non GxP systems, involving various functional areas to maintain quality and compliance. These reviews improved system reliability and reduced downtime by 10%. - Leading strategic discussions with senior stakeholders and cross-functional teams to align project goals and deliverables. This alignment led to the successful delivery of projects on time and within budget, enhancing stakeholder satisfaction. I excel in Quality Management, Change Management, and implementing preventive, detective, and corrective measures. I am adept at using Lean/Agile approaches and performing root cause analysis. Additionally, I am Medidata certified in RAVE SDBE and experienced in RAVE EDC, User Account Management, Site Management, and Study Build.

Stackforce AI infers this person is a Healthcare Compliance and Quality Assurance expert with extensive experience in Computer System Validation.

Location: Lucknow, Uttar Pradesh, India

Experience: 14 yrs 2 mos

Skills

Computer System Validation
Quality Assurance
Regulatory Compliance

Career Highlights

14 years of experience in Computer System Validation.
Led major projects for leading European pharmaceutical companies.
Achieved a 30% reduction in validation cycle time.

Work Experience

Infosys Consulting

Senior Consultant (4 yrs 3 mos)

Tata Consultancy Services

Associate Consultant (4 mos)

Assistant Consultant (2 yrs 8 mos)

It Analyst (2 yrs 11 mos)

Systems Engineer (4 yrs)

Education

Bachelor of Technology (B.Tech.) at Dr. A.P.J. Abdul Kalam Technical University

10+2 at St. James Sr. Sec. School, Hardoi U.P

AKSHAT SRIVASTAVA

Associate Consultant

Lucknow, Uttar Pradesh, India14 yrs 2 mos experience

Highly Stable

Key Highlights

14 years of experience in Computer System Validation.
Led major projects for leading European pharmaceutical companies.
Achieved a 30% reduction in validation cycle time.

Stackforce AI infers this person is a Healthcare Compliance and Quality Assurance expert with extensive experience in Computer System Validation.

Contact

Skills

Core Skills

Computer System ValidationQuality AssuranceRegulatory Compliance

Other Skills

JiraAgile & Waterfall MethodologiesCorrective and Preventive Action (CAPA)Functional TestingConfluenceTest PlanningITILVVQMSRequirements AnalysisSDLCCOTSDeviation ManagementUser Acceptance TestingManual TestingTeam Management

About

Experience

14 yrs 2 mos

Total Experience

9 yrs 11 mos

Average Tenure

4 yrs 3 mos

Current Experience

Infosys consulting

Senior Consultant

Mar 2022 – Present · 4 yrs 3 mos · Noida, Uttar Pradesh, India · Hybrid

Senior Consultant in Infosys Consulting’s Life Sciences with more than 13+ years of professional experience in Computer System Validation & Testing, Quality Assurance, Security & Compliance, Risk Management and delivering projects as Validation Manager and Test Lead/Manager.
Possess strong knowledge of 21 CFR part 11, GxP regulations, GAMP 5 guidelines and other regulatory processes.
Practical and comprehensive experience helping clients – across verticals – solve complex problems using a combination of design disciplines and methodologies
Defined end-to-end validation strategy for large business critical programs and IT computerized systems
Coordinating with Business & IT stakeholders to perform and review Functional Risk Assessment (FRA) – FMEA or CSA, Vendor Assessment, Backup and Recovery Assessments.
Conducting internal audits as part of audit readiness activities based on Client SOPs & checklist, ensuring compliance with regulatory standards and identifying areas for improvement.
Conducting Periodic Reviews of GxP & Non GxP systems and Compiling Periodic Review reports based on GAMP 5 categorization.
Handling multiple large projects, respond quickly to changing situations in complex environments
Leading strategic and tactical discussions with Senior stakeholders

JiraAgile & Waterfall MethodologiesCorrective and Preventive Action (CAPA)Quality AssuranceFunctional TestingConfluence+38

Tata consultancy services

4 roles

Associate Consultant

Oct 2021 – Feb 2022 · 4 mos

Defined end-to-end validation strategy for large business critical programs and IT computerized systems.
Managed the implementation and rollout of multiple systems.
Authored & reviewed End to End Validation deliverables including but not limited to – Change Request, High Level Risk Assessment (HLRA), Validation Plan (VP), User Requirement, Functional & Configuration specifications, Test Strategy Plan, Test design, Test runs, Operating Procedures, Traceability Matrix, Test Summary and Validation Report (VR).
Coordinated with Business & IT stakeholders to perform and review Functional Risk Assessment (FRA) – FMEA or CSA, Vendor Assessment, Backup and Recovery Assessments.
Executed Data Migration project involved in review of Migration Plan & Report.

Rave EDCAgile & Waterfall MethodologiesCorrective and Preventive Action (CAPA)Quality AssuranceFunctional TestingTest Planning+36

Assistant Consultant

Promoted

Jan 2019 – Sep 2021 · 2 yrs 8 mos

Managed the implementation and rollout of Clinical Trials Management Systems(CTMS).
Validated Medidata’s RAVE EDC and Rave Classic applications used for capturing Patient data during conduct of Clinical Trials.
Managed validation and rollout of Standards and Management system which provides a robust framework to effectively manage Clinical metadata.
Initiated and Executed Project for development, validation and implementation of SAP Business Objects 4.0 custom reports. These reports tracked various KPIs e.g.: Progress of Trial, Open/Closed Queries, Status of Data Entry in EDC System.
Responsible for validating and implementing the Trackwise system for Change Management & CAPA.
Validated Medidata’s eCOA, Patient Cloud and Science 37 DCT application used for Patient engagement
Authored & reviewed End to End Validation deliverables including but not limited to – Change Request, High Level Risk Assessment (HLRA), Validation Plan (VP), User Requirement, Functional & Configuration specifications, Test Strategy Plan, Test design, Test runs, Operating Procedures, Traceability Matrix, Test Summary and Validation Report (VR).
Coordinated with Business & IT stakeholders to perform and review Functional Risk Assessment (FRA) – FMEA or CSA, Vendor Assessment, Backup and Recovery Assessments.
Executed Data Migration project involved in review of Migration Plan & Report.
Clinical Study Build Programmer, Team Lead and line manager with 5+ years of experience in Clinical study build activities within Medidata Rave platform and Validation activities.
Good experience on Medidata RAVE with robust knowledge on end to end Clinical trial setup, Study testing, Study Amendment, User Account Management, PDF Generation, Data Extract, Report generation, tSDV setup, Site Management and Core Configuration.

Rave EDCAgile & Waterfall MethodologiesCorrective and Preventive Action (CAPA)Quality AssuranceFunctional TestingTest Planning+36

It Analyst

Promoted

Jan 2016 – Dec 2018 · 2 yrs 11 mos

Rave EDCCorrective and Preventive Action (CAPA)Quality AssuranceFunctional TestingTest PlanningRegulatory Compliance+31

Systems Engineer

Dec 2011 – Dec 2015 · 4 yrs

Worked as a Systems Engineer for the role of Test Administrator in Tata Consultancy Services, Gurgaon, Haryana. Validated the process workflows and the access rights, roles and responsibilities of the users and the approval lifecycle of the documents in the system. Reviewed and analyzed the System Integration Test scripts and User Acceptance Test scripts and helped the testing team update the testing approach as per the regulatory guidelines.

Quality AssuranceFunctional TestingTest PlanningRegulatory ComplianceSDLCComputer System Validation+12