Summary
Overview
Work History
Education
Skills
Websites
Timeline
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KALAIVANI P

KALAIVANI P

Business Architecture manager - Computer System Validation Specialist
Bangalore

Summary

A seasoned professional with 15 years of exceptional work experience in a wide range of roles such as Computer System Validation Specialist, system manager, senior analyst, verification and validation engineer etc. Experience in building and managing team of 60+ members Experience in managing stakeholders to handle demand and cost management In-depth knowledge of R&D IT clinical systems (CTMS, RTMS, EDC and DMW) Proficiency in leading and overseeing a group consisting of incident and problem managers, change and release managers, validation consultants, and subject matter experts Proficient in decommissioning enterprise-level systems like oracle clinical, ensuring smooth and hassle-free retirement of IT systems Leveraging expertise in risk assessment, IT retirement plans, and data migration planning, ensuring that projects are delivered successfully within the specified timelines Strong project management skills, including budget management, timeline management, and personnel management, ensuring project success and stakeholder satisfaction Effectively engaged in crucial roles, including authoring, reviewing and approving validation artifacts Demonstrated expertise in managing and leading teams of validation consultants, delivering high-quality work within project budgets and timelines Functional expertise in working within an agile framework, with experience in delivering successful projects through the iterative and collaborative approach of agile methodologies Deft in coordinating with cross-functional teams, managing project timelines, and delivering high-quality work within the fast-paced and dynamic environment of agile development Adept at working collaboratively with stakeholders, including business users, IT teams, and third-party vendors, at ensuring project requirements are met and stakeholders' expectations are exceeded Strong vendor management skills, including coordinating with vendors to complete IQ and OQ and assisting in vendor selection and contract design

Overview

15
15
years of professional experience

Work History

Business Architecture Manager

Accenture Services Pvt.Ltd
11.2023 - Current
  • Managed and motivated employees to be productive and engaged in work.
  • Accomplished multiple tasks within established timeframes.
  • Maximized performance by monitoring daily activities and mentoring team members.
  • Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
  • Cross-trained existing employees to maximize team agility and performance.
  • Provide end to end validation support to the IT systems in R&D area

Application Development – Associate Manager

Accenture Services Private Ltd
11.2021 - 11.2023
  • Supervised a team comprising 60+ validation, testing and compliance consultants
  • Increased the headcount of team from 7 to 60+ members team
  • Oversaw the development and maintenance of software applications and ensured that they were designed, developed, and tested to meet business requirements
  • Handled decommissioning of oracle clinical system
  • Effectively authored risk assessments, IT retirement plans, data migration plans, and reports
  • Ensured timely approval and extension of the SOW
  • Delivered high-quality deliverables within the specified deadlines
  • Determined suitable profiles and placed them on the project
  • Ensured adherence to GxP regulations and effective SOPs
  • Managed resources, including budgets, timelines, and personnel, to ensure successful project delivery
  • Handled project documentation like the creation of user requirements spec, requirements traceability matrix, IQ and OQ protocols, and iteration reports
  • Systematically reviewed validation documents like sops, system description, assessments (ISA, DIA, supplier) of client

Advanced Business Analyst & System Manager

Novo Nordisk Service Centre India Pvt. Ltd.
02.2017 - 11.2021
  • Collaborated with stakeholders to comprehend their business needs, collected and documented requirements, and translated them into technical specifications
  • Oversaw the projects from start to finish, including planning, executing and monitoring the project to ensure that it was delivered on time and within the defined budget
  • Identified suitable software solutions, designed the system architecture, and ensured that the system complied with quality standards
  • Planned the release as per the changes from Line of Business
  • Systematically reviewed changes utilizing a change management tool
  • Coordinated and collaborated with vendors to complete the IQ and OQ
  • Ensured that the system met business requirements and is in compliant with internal and external requirements
  • Conducted periodic reviews of the system
  • Coordinated with vendor selection and assist the sourcing team in designing contracts
  • Worked in close consultation with stakeholders, including business users, IT teams, and third-party vendors, to ensure that project requirements were met
  • Participated in PI planning and iteration review meetings as a delivery team member

Senior Analyst – Software Engineer

Accenture Services Pvt. Ltd.
02.2014 - 02.2017
  • Handled overall Qualification and Validation activities
  • Systematically reviewed and approved Requirement documents, Design documents, Test Protocols (IQ, OQ & PQ), pre-executed and post-executed test scripts in RQM
  • Reviewed codes developed by other team members to ensure compliance with coding standards, identify areas for improvement
  • Implemented the industry's best practices for software development, including design patterns, coding standards, and testing frameworks
  • Reviewed & approved Change control, Release Notes etc
  • Conducted internal audits in accordance with the checklist
  • Authored Qualification Summary Reports and Validation Summary Reports
  • Mentored junior analysts, fostering professional development while enhancing overall team performance.
  • Collaborated with cross-functional teams to identify areas of improvement, leading to increased operational effectiveness.

Senior Verification & Validation Engineer

IGate Computer Systems Pvt. Ltd.
04.2010 - 02.2014
  • Designed and executed test plans and test cases for the product or system under test
  • Involved in authoring master test plan (MTP)
  • Performed crucial verification and validation activities to ensure that the product or system met the customer's requirements and specifications
  • Developed a checklist to review executed and authored test scripts
  • Performed gap analysis in STM based on the various reports from VM
  • Delivered RTM, IRS and SRS review feedback to the project team
  • Provided quality and impact analysis for FCCC and FCCC approval
  • Documented test results, and reports on the quality of the product or system under test to stakeholders
  • Conducted defect analysis, collaborated with the respective project team, and worked on defect resolution (RCA & CAPA)

Education

Bachelor of Engineering - Electronics and Communication

Anna University
Tamil Nadu
01.2005

Skills

  • System validation expertise
  • System operations management
  • Contract management
  • Decision-making
  • Supplier relationship management
  • Stakeholder collaboration
  • Scrum and Kanban practices
  • Conducting internal IT audits
  • System quality assurance
  • Effective documentation methods
  • Resource allocation management
  • Risk management assessment
  • Regulatory inspections
  • Quality assurance in documentation
  • Quality assurance testing
  • Development of test protocols
  • Test plan development
  • Test case scripting
  • Change management expertise
  • Team leadership
  • HP ALM expertise
  • Experience with IBM RQM
  • Experience with BMC Remedy

Timeline

Business Architecture Manager

Accenture Services Pvt.Ltd
11.2023 - Current

Application Development – Associate Manager

Accenture Services Private Ltd
11.2021 - 11.2023

Advanced Business Analyst & System Manager

Novo Nordisk Service Centre India Pvt. Ltd.
02.2017 - 11.2021

Senior Analyst – Software Engineer

Accenture Services Pvt. Ltd.
02.2014 - 02.2017

Senior Verification & Validation Engineer

IGate Computer Systems Pvt. Ltd.
04.2010 - 02.2014

Bachelor of Engineering - Electronics and Communication

Anna University
KALAIVANI PBusiness Architecture manager - Computer System Validation Specialist