Summary
Overview
Work History
Education
Skills
Roles And Responsibilities
Career Experience
Custom Section
Summary Of Experience
Certification
Interests
References
Timeline
Generic
Deepak Deshpande

Deepak Deshpande

Quality Assurance, Computer System Validation (CSV), Audits, Testing, and Project Management.
Bengaluru,Karnataka

Summary

15+ years of experience in Quality Assurance, Computer System Validation (CSV), Audits, Testing, and Project Management.

- Expertise in validating computerized systems as per GxP guidelines, ensuring compliance with regulatory standards (FDA 21 CFR Part 11, EU Annex 11).

- Proficient in SDLC, STLC, and test management tools (JIRA, ClearQuest).

- Skilled in drafting and executing validation documents (URS, FRS, IQ/OQ/PQ, RTM, VMP).

- Strong leadership and team management experience, with a focus on delivering high-quality results in IT, clinical, manufacturing, and quality software systems.

Overview

21
21
years of professional experience
5
5
years of post-secondary education
1
1
Certification
3
3
Languages

Work History

Delivery Module Lead

Mphasis
Bengaluru, India
07.2022 - Current
  • Working as effective team member providing independent review and guidance on deliverables used to develop, implement, and maintain IT/clinical/manufacturing/quality software
  • Worked on functional and Automation testing
  • Working experience in change request team and well verse with change management process
  • Experience in reviewing and authoring end-to-end Validation SDLC Life-cycle documents
  • Proficiency in creating and executing scripts (IQ /OQ) to ensure operational quality, system integrity and verify system meets user requirements for Software application
  • Experience in working as Project lead, I demonstrate leadership qualities, acknowledge, develop, communicate & implement a validation strategy to ensure compliance
  • Experience in working on SAP ERP applications, Risk Evaluation Mitigation systems and Life sciences applications
  • Conducting routine Internal Quality Audits, support client audits and involved in Periodic reviews
  • Creating and Review of documents like Validation Master Plan, Validation Report
  • Successfully delivered on tasks within tight deadlines.
  • Engaged with stakeholders to build relationships and brand awareness.
  • Assisted in the recruitment process by interviewing potential candidates and making informed recommendations for hiring decisions based on technical capabilities and cultural fit considerations.
  • Conducted thorough quality assurance testing on all developed modules, ensuring optimal functionality before delivery to clients.
  • Mentored junior team members, fostering their growth and development within the company.
  • Streamlined communication within the team, resulting in improved collaboration and faster project completion times.
  • Assigned tasks to IT personnel and junior module staff, delegating work orders based on individual employee proficiencies.
  • Optimized module development processes, leading to increased efficiency and better quality outcomes.
  • Resolved conflicts that arose during project execution through effective problem-solving skills combined with strong interpersonal abilities.

Senior Validation Engineer

Ametek Instruments
08.2020 - 07.2022
  • Worked as the QA-CSV with the Engineering, Quality Control, IT and Validation organizations to support company goals, client projects, continuous improvement initiatives and as a lead and Senior QA
  • Created the documents required for the development and validation of the computerized system
  • Involved in the Risk assessments, Data privacy Assessments and Vendor assessments
  • Provide input into Requirements Specifications for inclusion of Data Integrity and CSV requirements
  • Supports during Data migrations and support for different vendors
  • Provided QA support for deviations related to Engineering, Facilities, Automation, IT, Quality Control and Validation groups
  • Performed Root Cause Analysis (RCA) and investigations to evaluate product impact and assist in identifying Corrective and Preventive Actions (CAPA)

Chief Engineer

Samsung India
12.2007 - 06.2015

Led validation and testing efforts for IT and manufacturing systems, ensuring compliance with regulatory standards.

- Developed and executed test protocols (IQ, OQ, PQ) for software and hardware systems.

  • Executed detailed feasibility studies for accurate project planning and risk mitigation.
  • Collaborated frequently with other departments to ensure alignment of engineering goals.
  • Identified and resolved complex technical issues for improved system performance.
  • Translated blueprints into workable plans contributing to successful project implementation.

- Mentored and managed teams, ensuring timely delivery of high-quality validation deliverables.

- Collaborated with cross-functional teams to implement continuous improvement initiatives.

Test Lead

Vista Infotech Pvt Ltd
Bengaluru
07.2004 - 11.2007

Vista Infotech Pvt Ltd | July 2004 – November 2007

- Managed testing activities for software applications, including functional, regression, and integration testing.

- Developed test documentation (test cases, scripts, and reports) and ensured adherence to project timelines.

- Conducted user acceptance testing (UAT) and provided support for system deployments

Education

Bachelor of Engineering - Computer Science

PDA College of Engineering
Gulbarga
06.1997 - 12.2001

Skills

Validating Computerized Systems

SDLC

STLC

Bug Life Cycle

Bug Reporting

Test Documentation

UI testing

Functional Testing

Regression Testing

Sanity Testing

Usability Testing

Smoke Testing

Component Testing

Integration Testing

End-To-End Testing

Compatibility Testing

UAT

Black Box Testing Techniques

Mentoring

Leading

Managing

Validation Plan

Validation Summary report

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Roles And Responsibilities

  • Team Member, Working as effective team member providing independent review and guidance on deliverables used to develop, implement, and maintain IT/clinical/manufacturing/quality software.
  • Functional and Automation Testing, Worked on functional and Automation testing.
  • Change Management, Working experience in change request team and well verse with change management process.
  • Validation SDLC Life-cycle, Experience in reviewing and authoring end-to-end Validation SDLC Life-cycle documents.
  • Script Execution, Proficiency in creating and executing scripts (IQ /OQ) to ensure operational quality, system integrity and verify system meets user requirements for Software application.
  • Project Lead, Experience in working as Project lead, I demonstrate leadership qualities, acknowledge, develop, communicate & implement a validation strategy to ensure compliance.
  • SAP ERP Applications, Experience in working on SAP ERP applications, Risk Evaluation Mitigation systems and Life sciences applications.
  • Internal Quality Audits, Conducting routine Internal Quality Audits, support client audits and involved in Periodic reviews.
  • Document Review, Creating and Review of documents like Validation Master Plan, Validation Report.

Career Experience

  • Delivery Module Lead, Mphasis (HP), 07/01/22, Present
  • Senior Validation engineer, Ametek Instruments, 08/01/20, 07/31/22
  • Chief engineer, Samsung India, 12/01/07, 06/30/15
  • Test Lead, Vista Infotech Pvt Ltd, 07/01/04, 11/30/07

Custom Section

  • Ametek Instruments, Sr Validation engineer, Worked as the QA-CSV with the Engineering, Quality Control, IT and Validation organizations to support company goals, client projects, continuous improvement initiatives and as a lead and Senior QA., Created the documents required for the development and validation of the computerized system., Involved in the Risk assessments, Data privacy Assessments and Vendor assessments., Provide input into Requirements Specifications for inclusion of Data Integrity and CSV requirements., Supports during Data migrations and support for different vendors., Provided QA support for deviations related to Engineering, Facilities, Automation, IT, Quality Control and Validation groups. Performed Root Cause Analysis (RCA) and investigations to evaluate product impact and assist in identifying Corrective and Preventive Actions (CAPA).
  • Mphasis, Delivery Module Lead

Summary Of Experience

  • Total 15 + years of Professional experience in Quality Assurance, Computer system Validation, Audits, Testing and Project management.
  • Bachelor of Engineering in Computer Sciences

Certification

GAMP 5 Certification* - *ISTQB Certified Tester

Interests

Music, Acting, Mimicry

References

References available upon request.

Timeline

Delivery Module Lead

Mphasis
07.2022 - Current

GAMP 5 Certification* - *ISTQB Certified Tester

12-2020

Senior Validation Engineer

Ametek Instruments
08.2020 - 07.2022

Chief Engineer

Samsung India
12.2007 - 06.2015

Test Lead

Vista Infotech Pvt Ltd
07.2004 - 11.2007

Bachelor of Engineering - Computer Science

PDA College of Engineering
06.1997 - 12.2001
Deepak DeshpandeQuality Assurance, Computer System Validation (CSV), Audits, Testing, and Project Management.