Nikhil
Q&A Analyst at Deloitte Audit and Enterprise Risk Services
House No. 1068A, Dr. Mukherjee Nagar, Delhi 100009
"Focused individual with good Validation skills"
ABOUT ME

Nikhil is a Consultant with the Life Science and Health Care Practice of Deloitte and has 4 years of experience in providing Computerized System Validation (CSV) services for pharmaceutical companies. Prior to Deloitte, he was providing consulting services for a leading pharmaceutical company based in Germany wherein he worked on validating multiple applications relating to Clinical Reporting Clinical Protocol Development and Pharmacovigilance.

He has knowledge of 21 CFR part 11, GxP regulations, and regulatory processes and possesses a firm understanding of validation and testing activities required in life sciences industry.

He has experience include analysis of user requirements, risk analysis of requirements, development of validation/Test plan, validation/Test summary report, test protocol, test defect summary report, exit criteria determination, test objectives, tasks and

...

Nikhil is a Consultant with the Life Science and Health Care Practice of Deloitte and has 4 years of experience in providing Computerized System Validation (CSV) services for pharmaceutical companies. Prior to Deloitte, he was providing consulting services for a leading pharmaceutical company based in Germany wherein he worked on validating multiple applications relating to Clinical Reporting Clinical Protocol Development and Pharmacovigilance.

He has knowledge of 21 CFR part 11, GxP regulations, and regulatory processes and possesses a firm understanding of validation and testing activities required in life sciences industry.

He has experience include analysis of user requirements, risk analysis of requirements, development of validation/Test plan, validation/Test summary report, test protocol, test defect summary report, exit criteria determination, test objectives, tasks and scenarios, data mining for creation of appropriate aggregate data, change management, regression analysis and managing offshore teams and has received a 90% customer satisfaction index for all the projects managed.

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SKILLS & CAPABILITIES
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    ARISg
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    HP Application Lifecycle Management
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    IBM COGNOS
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    IBM DOORS
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    Oracle Clinical and RDC
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SAP Securities SQL Team Management Test Execution Test Management Test Planning Test Strategy Validation Veeva Vault
SKILL COMMENDATIONS
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SPECIALIZATION
(2 out of 2 Specializations)
TRAITS & STRENGTHS
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MILESTONES TIMELINE
Work Milestones (4 most recent out of 7)
Project Milestones (4 most recent out of 5)
Academic Milestones (1 most recent out of 1)
Project Milestones
You have not added any Project Milestones
Work Milestones
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Deloitte Audit and Enterprise Risk Services - Q&A Analyst
Jan 2015 - Present (6 years and 4 months)
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Deloitte Audit and Enterprise Risk Services - Q&A Lead - Offshore
May 2014 - Dec 2014 (7 months)
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Deloitte Audit and Enterprise Risk Services - Enterprise Risk Consultant
Apr 2014 - Present (7 years and 1 month)
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TATA Consultancy Services - Test Analyst
Feb 2014 - Apr 2014 (2 months)
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TATA Consultancy Services - Test Analyst
Jul 2013 - Feb 2014 (7 months)
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TATA Consultancy Services - Test Analyst
Jun 2011 - Apr 2014 (2 years and 10 months)
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TATA Consultancy Services - Test Analyst
Jun 2011 - Jul 2013 (2 years and 1 month)
Academic Milestones
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Cochin University of Science and Technology - B. Tech. Electrical and Electronics Engineering
Jun 2007 - Jun 2011 (4 years)
WORK MILESTONES
Deloitte Audit and Enterprise Risk Services
Deloitte Audit and Enterprise Risk Services
Deloitte Audit and Enterprise Risk Services
Apr 2014 - On Going | Gurgaon
Work Type: Full-Time
Industry: Software
JOB TITLES, RESPONSIBILITIES & CONTRIBUTIONS
Enterprise Risk Consultant
Apr 2014 - On Going
  • Involved in the planning, authoring, execution and review of test scripts relating to various applications and processes
  • Involved in data mining for creation of appropriate aggregate data to be used in testing process
  • Authored and reviewed Test Summary Report, Compliance/Validation Summary Report and Traceability Matrix
  • Performed change management and regression analysis
  • Maintained and reviewed Traceability matrix to ensure traceability of requirement to test scripts
  • Checked the compliance of various pharmaceutical and health care companies to the guidelines set by FDA and other regulatory agencies.
  • Validated the technical and technology related solutions of health care companies in accordance with GxP and other regulatory guidelines.
  • Review of SDLC deliverables such as Compliance Plan, Compliance Summary Report, UAT Summary Report, OQ and PQ to meet the client' SOPs
  • Involved in analysis of Validation Plan and Test Strategy
icon Project Milestones: BQ Document Management System - Q&A Lead - Offshore, SAP Securities - Q&A Analyst
icon Awards Received: On the Spot Award
Q&A Lead - Offshore
May 2014 - Dec 2014
  • Team Lead (Offshore)
icon Project Milestones: BQ Document Management System, BQ Document Management System - Q&A Lead - Offshore, SAP Securities - Q&A Analyst
icon Work Milestones: Deloitte Audit and Enterprise Risk Services - Enterprise Risk Consultant
icon Awards Received: On the Spot Award
Q&A Analyst
Jan 2015 - On Going
  • Post review of test scripts to validate the roles assignment to users
icon Project Milestones: SAP Securities, BQ Document Management System - Q&A Lead - Offshore, SAP Securities - Q&A Analyst
icon Work Milestones: Deloitte Audit and Enterprise Risk Services - Enterprise Risk Consultant
icon Awards Received: On the Spot Award
TATA Consultancy Services
TATA Consultancy Services
TATA Consultancy Services
Jun 2011 - Apr 2014 | Gurgaon
Work Type: Full-Time
Industry: Software
JOB TITLES, RESPONSIBILITIES & CONTRIBUTIONS
Test Analyst
Jun 2011 - Apr 2014
  • Involved in analysis of Validation Plan and Test Strategy
  • Review of SDLC deliverables such as Compliance Plan, Compliance Summary Report, UAT Summary Report, OQ and PQ to meet the client's SOPs
  • Involved in the planning, authoring, execution and review of test scripts relating to various applications and processes
  • Involved in data mining for creation of appropriate aggregate data to be used in testing process
  • Authored and reviewed Test Summary Report
  • Performed change management and regression analysis
  • Maintained and reviewed Traceability matrix to ensure traceability of requirement to test scripts
  • Was responsible for data mining, data validation checks and data transformation checks for data collected from various sources
  • Subject matter expert (related to ARISg and the issues associated with the reports)
icon Project Milestones: Clinical Reporting - Test Analyst, Clinical Protocol Development - Test Analyst, Pharmacovigilance - Test Analyst
icon Achievements: Process Development
icon Awards Received: On the Spot Award, Appreciation Award, Appreciation Award
Test Analyst
Feb 2014 - Apr 2014
  • Testing the application and preparation of test data
icon Project Milestones: Clinical Reporting, Clinical Reporting - Test Analyst, Clinical Protocol Development - Test Analyst, Pharmacovigilance - Test Analyst
icon Work Milestones: TATA Consultancy Services - Test Analyst
icon Achievements: Process Development
icon Awards Received: On the Spot Award, Appreciation Award, Appreciation Award
Test Analyst
Jul 2013 - Feb 2014
  • Authoring and reviewing Compliance/Test Plan, Compliance/Test Report, Test Protocol, Test Summary Report, User/Functional Requirements, Test Scripts
  • Team Lead
icon Project Milestones: Clinical Protocol Development, Clinical Reporting - Test Analyst, Clinical Protocol Development - Test Analyst, Pharmacovigilance - Test Analyst
icon Achievements: Process Development
icon Awards Received: On the Spot Award, Appreciation Award, Appreciation Award
icon Work Milestones: TATA Consultancy Services - Test Analyst
Test Analyst
Jun 2011 - Jul 2013
  • Subject matter expert (related to ARISg and the issues associated with the reports)
  • Team Lead (Nov 2012 – July 2013)
icon Project Milestones: Pharmacovigilance, Clinical Reporting - Test Analyst, Clinical Protocol Development - Test Analyst, Pharmacovigilance - Test Analyst
icon Work Milestones: TATA Consultancy Services - Test Analyst
icon Achievements: Process Development
icon Awards Received: On the Spot Award, Appreciation Award, Appreciation Award
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PROJECT MILESTONES
SAP Securities
SAP Securities
SAP Securities
Jan 2015 - On Going | Gurgaon, Haryana, India
ROLE, RESPONSIBILITIES & CONTRIBUTIONS
Q&A Analyst
Jan 2015 - On Going
  • Post review of test scripts to validate the roles assignment to users
icon Work Milestones: Deloitte Audit and Enterprise Risk Services, Deloitte Audit and Enterprise Risk Services - Enterprise Risk Consultant
icon Project Milestones: BQ Document Management System - Q&A Lead - Offshore, SAP Securities - Q&A Analyst
icon Awards Received: On the Spot Award
BQ Document Management System
BQ Document Management System
BQ Document Management System
May 2014 - Dec 2014 | Gurgaon, Haryana, India
																		Analyze the business process and validate the implementation of various technologies to meet the compliance of regulatory agencies. Authoring and reviewing Compliance/Test Plan, Compliance/Test Report, Test Protocol, Test Summary Report, User/Functional Requirements, Test Scripts and Traceability Matrix.
																	
ROLE, RESPONSIBILITIES & CONTRIBUTIONS
Q&A Lead - Offshore
May 2014 - Dec 2014
  • Team Lead (Offshore)
icon Work Milestones: Deloitte Audit and Enterprise Risk Services, Deloitte Audit and Enterprise Risk Services - Enterprise Risk Consultant
icon Project Milestones: BQ Document Management System - Q&A Lead - Offshore, SAP Securities - Q&A Analyst
icon Awards Received: On the Spot Award
Clinical Reporting
Clinical Reporting
Clinical Reporting
Feb 2014 - Apr 2014 | Gurgaon, Haryana, India
																		Analyzing and testing of clinical reports, validation of data with the database and ensuring the compliance required by various regulating agencies.
																	
ROLE, RESPONSIBILITIES & CONTRIBUTIONS
Test Analyst
Feb 2014 - Apr 2014
  • Testing the application and preparation of test data
icon Work Milestones: TATA Consultancy Services, TATA Consultancy Services - Test Analyst
icon Project Milestones: Clinical Reporting - Test Analyst, Clinical Protocol Development - Test Analyst, Pharmacovigilance - Test Analyst
icon Achievements: Process Development
icon Awards Received: On the Spot Award, Appreciation Award, Appreciation Award
Clinical Protocol Development
Clinical Protocol Development
Clinical Protocol Development
Jul 2013 - Feb 2014 | Gurgaon, Haryana, India
																		Testing the organization of data and the structure of clinical trial protocol (CTP). The main focus was to check that the various data required for generation of a CTP is present in an organized format and that the links of various activities to be performed in a particular visit is correct. It also dealt with testing the Meta Data Repository (MDR) and extraction of data present in MDR to CTP.
																	
ROLE, RESPONSIBILITIES & CONTRIBUTIONS
Test Analyst
Jul 2013 - Feb 2014
  • Authoring and reviewing Compliance/Test Plan, Compliance/Test Report, Test Protocol, Test Summary Report, User/Functional Requirements, Test Scripts
  • Team Lead
icon Work Milestones: TATA Consultancy Services, TATA Consultancy Services - Test Analyst
icon Project Milestones: Clinical Reporting - Test Analyst, Clinical Protocol Development - Test Analyst, Pharmacovigilance - Test Analyst
icon Achievements: Process Development
icon Awards Received: On the Spot Award, Appreciation Award, Appreciation Award
Pharmacovigilance
Pharmacovigilance
Pharmacovigilance
Jun 2011 - Jul 2013 | Gurgaon, Haryana, India
																		Analysis of various adverse events reports that are sent to regulatory agencies (eg. PSUR, DSUR, Timeline Reports, etc.). It required the validation of the database (ARISg and IBM COGNOS) and testing the performance related issues of the reports.
																	
ROLE, RESPONSIBILITIES & CONTRIBUTIONS
Test Analyst
Jun 2011 - Jul 2013
  • Subject matter expert (related to ARISg and the issues associated with the reports)
  • Team Lead (Nov 2012 – July 2013)
icon Work Milestones: TATA Consultancy Services, TATA Consultancy Services - Test Analyst
icon Project Milestones: Clinical Reporting - Test Analyst, Clinical Protocol Development - Test Analyst, Pharmacovigilance - Test Analyst
icon Achievements: Process Development
icon Awards Received: On the Spot Award, Appreciation Award, Appreciation Award
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ACADEMIC MILESTONES
Cochin University of Science and Technology
Cochin University of Science and Technology
Cochin University of Science and Technology
Jun 2007 - Jun 2011
Bachelors
Degree/Certification: B. Tech.
Major: Electrical and Electronics Engineering
Total Aggregate: 76.11%
icon Achievements: Educational Distinction
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PORTFOLIO GALLERY
CLIENTS & COLLABORATORS
Pepsi Co.
Pepsi Co.
Johnson & Johnson
Johnson & Johnson
Boehringer Ingelheim
Boehringer Ingelheim
HONOR & RECOGNITION

On the Spot Award 2014

Appreciation Award 2014

Appreciation Award 2013

On the Spot Award 2012
ACCOMPLISHMENTS & ACHIEVEMENTS

Process Development

Educational Distinction
MEMBERSHIPS & ORGANIZATIONS
COMMENDATIONS & TESTIMONIALS
Commendations & Testimonials Empty