Nikhil
Nikhil's
Brand Power
Nikhil Prakash
"Focused individual with good Validation skills"
Job Title: Enterprise Risk Consultant
Company/School: Deloitte Audit and Enterprise Risk Services
Location: House No. 1068A, Dr. Mukherjee Nagar, Delhi 100009
Expertise: Computer Systems Validation, Testing, Pharmacovigilance, 21 CFR Part 11, GxP Guidelines
About Nikhil

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.

WORK HISTORY
Deloitte Audit and Enterprise Risk Services
Apr 2014 - On Going
Gurgaon,
Job Title: Enterprise Risk Consultant and 2 other
Work Type: Full-Time
Industry: Software
Work Phone: 9654338055
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
Q&A Lead - Offshore
May 2014 - Dec 2014
Team Lead (Offshore)
Q&A Analyst
Jan 2015 - On Going
Post review of test scripts to validate the roles assignment to users
Nikhil has associated this Work History with :
On the Spot Award
BQ Document Management System, SAP Securities
TATA Consultancy Services
Jun 2011 - Apr 2014
Gurgaon,
Job Title: Test Analyst and 3 other
Work Type: Full-Time
Industry: Software
Work Phone: 9654338055
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)
Test Analyst
Feb 2014 - Apr 2014
Testing the application and preparation of test data
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
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)
Nikhil has associated this Work History with :
Process Development
On the Spot Award, Appreciation Award, Appreciation Award
Clinical Reporting, Clinical Protocol Development, Pharmacovigilance
EDUCATION
B. Tech.
Cochin University of Science and Technology
Jun 2007 - Jun 2011
Kochi, Kerala, India
Bachelors
Electrical and Electronics Engineering
Nikhil has associated this Education with :
Educational Distinction
SKILLS
Work Skills
HP Application Lifecycle Management
Veeva Vault
ARISg
SAP Securities
IBM DOORS
SQL
Oracle Clinical and RDC
IBM COGNOS
View More(3)
Soft Skills
Team Management
Skills Interested
Validation,Test Planning,Test Strategy,Test Management,Test Execution
PROJECTS
SAP Securities
Jan 2015 - On Going
Gurgaon, Haryana, India
Job Title: Q&A Analyst
Q&A Analyst
Jan 2015 - On Going
Post review of test scripts to validate the roles assignment to users
Nikhil has associated this Project with :
Deloitte Audit and Enterprise Risk Services
BQ Document Management System
May 2014 - Dec 2014
Gurgaon, Haryana, India
Job Title: Q&A Lead - Offshore
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.
Q&A Lead - Offshore
May 2014 - Dec 2014
Team Lead (Offshore)
Nikhil has associated this Project with :
On the Spot Award
Deloitte Audit and Enterprise Risk Services
Clinical Reporting
Feb 2014 - Apr 2014
Gurgaon, Haryana, India
Job Title: Test Analyst
Analyzing and testing of clinical reports, validation of data with the database and ensuring the compliance required by various regulating agencies.
Test Analyst
Feb 2014 - Apr 2014
Testing the application and preparation of test data
Nikhil has associated this Project with :
TATA Consultancy Services
View More (2)
SPECIALIZATION
Industry Proficiency Program - Life Science
Aug 2014
A Deloitte internal certification confirming that the associate has working knowledge of the Life Science Industry.
ISTQB Certification
Dec 2012
Internationally recognized certification confirming the competencies and skills of an efficient Tester
AWARDS
On the Spot Award
Dec 2014
Deloitte Internal
Recognizes my contribution towards proper execution of the project and timely delivery of work packets
Appreciation Award
Feb 2014
TATA Consultancy Services
Achieving high Customer Satisfaction Index for the project I was managing. 
Appreciation Award
Jul 2013
TATA Consultancy Services
Achieving high Customer Satisfaction Index for the project I was managing. 
View More (1)
ACHIEVEMENTS
Process Development
Dec 2012
Developed a more efficient system of analyzing defects from the testing tool and checking the Test Execution Status and Test coverage of requirements
Educational Distinction
Jun 2011
Among the top 8 students of Electrical and Electronics department to secure a distinction.