CURRICULUM VITAE
EDUCATION & CERTIFICATION
Mahesh Anumakonda
Manager – Compliance
&Validation
CONTACT
Phone: +91 9989195419
Email:
anumakondamahesh.j@gmail.com
LinkedIn Profile:
https://www.linkedin.com/in/mahesh-
anumakonda/
SUMMARY
Proactive, performance driven
professional with 16+ years of expertise
in Test Management, Validation
Management, Project Management,
Computer System Validation in the
area of Life sciences, Pharmaceutical
& Health care domains. Keen
understanding of business requirements
& prioritization. Committed to on-time
project deliveries with quality
assurance & ensuring compliance.
KEY SKILLS
• Test Planning & Execution
• Project Management
• Computer System Validation
• Verification & Validation
• LIMS (Laboratory Information
Management system)
• Waterfall & Agile Methodology
• GAMP, GxP, 21 CRF Part 11
• Process Improvements
• Cross-Functional Collaboration
• Team Management
• Defect Management
• Change Management
• Deviation Management
• Risk Assessment & Mitigation
• Audit Management
M. Sc (Information Technology) 2002
BCA (Batchelor of Computer Application) 2000
________________________________________________________________
Certified Scrum Master (CSM) Nov ’19
Project Management Professional Aug ‘23
QMS Auditor / lead Auditor Jun ’22
AWS Cloud Practitioner Jan ’23
PROFESSIONAL EXPERIENCE
Previous Company: Caliber Technologies Pvt Ltd. Apr’ 06 – Jul’ 21
Current Company: Freyr Software Solution Pvt Ltd. Jul’ 21 – Present Date
________________________________________________________________
Jul’ 21 – Present Date
Manager –Compliance & Validation Project: Freyr Submit Pro, SPAR, DMS
Responsible to participate in Testing & validation of Products/projects in
adherence to applicable global regulatory requirements, policies, and
standard operating procedures.
• Conducting Testing & validation activities to meet regulatory
requirements and industry standards, ensuring compliance and
customer satisfaction.
• Leading and manage a team, including task assignment, performance
evaluation, and mentoring.
• Define and oversee the creation of test scripts & OQ scripts based on
product/ project requirements and user stories.
• Executing the product / project using Waterfall / Agile methodology by
following Scrum, Sprint planning & Backlog management.
• Involving in sprint planning, sprint meetings, sprint demo
and retrospective meetings.
• Prepare or Review SDLC & validation documents like Test Plan,
Validation Master Plan (VMP), Validation Plan (VP), Strategy, Approach,
Functional Risk Assessment (FRA), Requirements Traceability Matrix
(RTM), Test scripts & OQ Script, Test & Validation Summary report &
Release Note documents
• Performing quality gate review and ensure Qualification documents IQ,
OQ, UAT, PQ cases are prepared and perform system
validation/qualification before releasing the product/ project as per
regulatory requirements.
• Ensuing that product meets with 21 CRF Part 11 regulatory requirements.
• Provide implementation (on-premises/SaaS) upgrade, project teams
with (expert) computer systems validation (CSV) guidance.
• Provide subject matter expertise while working closely with cross-
functional teams to ensure that the requirements are defined clearly,
and specifications/deliverables are drafted in compliant formats.
• Participate in process improvement and risk management activities for
automated systems and maintenance of a compliant, efficient, and
integrated system until system retirement.
• Ensure that the testing process aligns with industry standards, regulations,
and compliance requirements (ISO, GxP, GAMP).
• Facing or facilitating internal / external audits (ISO / Client).
Page 1 of 3

TYPE OF TESTING
• Smoke testing, Functional Testing,
Regression Testing, Integration
Testing, System Testing,
Compatibility Testing, Performance
Testing, API Testing, Automation
Testing.
SOFTWARE /TOOLS
• Database: SQL, Oracle
• Tool: Microsoft TFS/ ADO, JIRA,
VISIO, Selenium, Test Complete,
Soap UI, RPA UI Path, Postman,
JMeter, Load Complete, VSS, Git,
Jenkin, Azure DevOps, Azure, AWS
• Programming: Java, Java script,
VB Script, and HTML
DOMAIN EXPOSURE
• Life sciences - Pharmaceutical
• Health Care
TRAININGS
• Leadership training by Nalsar
university.
• Project Management professional
training.
CURRICULUM VITAE
PROFESSIONAL EXPERIENCE
Previous Company: Caliber Technologies Pvt Ltd. Apr’ 06 – Jul’ 21
Apr ’07 - Mar ’10 SQA Engineer
Apr ’07 - Mar ’10 Sr. SQA Engineer
Apr ’10 - Mar ’13 Team Lead QA
May’13 - Apr ‘14 Project Lead - QA
Apr’15 - Mar ‘18 Associate QA Manager
Apr ’18 - Jun ’21 Manager QA - Products
Project: Caliber LIMS, QAMS, DMS, N5CMS
Responsible for Testing & Validation Management to provide quality
delivery to clients across multiple Products (Laboratory Information
Management System, Quality Assurance Management System, - Document
Management System, N5CMS- Training Management System).
• Establishing and enforcing standard test processes and deliverables
(including defect management and quality metric reporting) within the
gated process to streamline testing and support automation and
manual testing efforts.
• Supervising team members for ensuring timely project completion;
developing quality standards through participating in the initial
software development stages; validating and enhancing the existing
plan and strategy.
• Preparing, designing, and leading the test strategy and test plan for all
products/projects; reviewing activities such as requirements review,
design review, and test case review
• Executing the product / project using Agile methodology by following
Scrum, Sprint planning & Backlog management.
• Coordinate and oversee the execution of test cases, including manual
and automated testing, ensuring comprehensive coverage.
• Implement defect tracking and management process, prioritizing issues
and ensuring timely resolution.
• Ensure that the software meets quality standards and complies with
project specifications and industry best practices.
• Set up and maintain test environments that mimic production
conditions to facilitate accurate testing.
• Prepare or Review SDLC & validation documents like Test Plan,
Validation Master Plan (VMP), Validation Plan (VP), Strategy, Approach,
Functional Risk Assessment (FRA), Requirements Traceability Matrix
(RTM), Test scripts & OQ Script, Test & Validation Summary report &
Release Note documents
• Ensure IQ, OQ, UAT, PQ cases are prepared and perform system
validation/qualification before releasing the product.
• Ensuing that product meets with 21 CRF Part 11 regulatory requirements.
• Oversee the creation and maintenance of automated test scripts,
optimizing test coverage and efficiency.
• Identify and assess project risks related to testing and implement
mitigation strategies.
• Act as a bridge between the testing team and project stakeholders,
providing regular updates on testing progress and issues.
• Generate and distribute comprehensive test reports, including test
results, defect status, and test coverage.
•
Page 2 of 3
 CURRICULUM VITAE

PROFESSIONAL EXPERIENCE

• Continuously evaluate and improve testing processes, tools, and

methodologies to enhance efficiency and effectiveness.
• Allocate testing resources efficiently, ensuring that the team has the
necessary skills and tools to perform their tasks effectively.
• Maintain SDLC documentation of test processes, test plans, and test
cases for future reference and audits. Ensure that the testing process
aligns with industry standards, regulations, and compliance
requirements (ISO, GxP, GAMP).
• Manage the testing budget, tracking expenses and ensuring cost-
effective testing solutions.
• Provide training and skill development opportunities for the testing team
to enhance their capabilities.
• Focus on delivering high-quality products and services that meet or
exceed customer expectations.

Page 3 of 3