Upload Button Icon Add office photos
Engaged Employer

i

This company page is being actively managed by Capgemini Team. If you also belong to the team, you can get access from here

Capgemini Verified Tick

Compare button icon Compare button icon Compare
3.7

based on 40.6k Reviews

Proud winner of ABECA 2024 - AmbitionBox Employee Choice Awards

zig zag pattern zig zag pattern
filter salaries All Filters

1582 Capgemini Jobs

GXP - Computerized System Validation SME

9-12 years

Bangalore / Bengaluru

GXP - Computerized System Validation SME

Capgemini

posted 13hr ago

Job Role Insights

Flexible timing

Job Description


 About The Role : 
  • Ensure Review and Approval of planning, execution and documentation of Change Management Activities (at Asses / Review states); along with associated lifecycle documents and test documents for Change Lifecycle by maintaining the IT Compliance standards.
  • Working on Defect Management, CAPA and Deviation documentation, review and approval.
  • working on testing and validation management tools like ServiceNow, HP ALM, Document Management (GDRS/ EDMS), or equivalent tools, etc.
  • Responsible for the review and approval of Test Scripts and executed test cases to assure compliance with good documentation practices.
  • Experienced in authoring & review of validation documentation such as URS, FRS, and SDS, Validation Plan, Issues Log, Design Review, IQ Protocol/Report, OQ


  •  

    Primary Skills 
  • Validation SME
  • Ensure Review and Approval of planning, execution and documentation of Change Management Activities (at Asses / Review states); along with associated lifecycle documents and test documents for Change Lifecycle by maintaining the IT Compliance standards.
  • Working on Defect Management, CAPA and Deviation documentation, review and approval.
  • working on testing and validation management tools like ServiceNow, HP ALM, Document Management (GDRS/ EDMS), or equivalent tools, etc.


  •  

    Secondary Skills 
  • Responsible for the review and approval of Test Scripts and executed test cases to assure compliance with good documentation practices.
  • Experienced in authoring & review of validation documentation such as URS, FRS, and SDS, Validation Plan, Issues Log, Design Review, IQ Protocol/Report, OQ
  • Protocol/Report, Test Cases, Test executions, Trace Matrix, and Validation report, etc.
  • Research in supporting systems (e.g., GDRS, ServiceNow, EDMS, etc.) that store the records to be reviewed
  • Sign & Approve request forms for HPQC as IT Compliance approver.
  • Individual contributor for Quality, Compliance, and Good Documentation Practices

  • Employment Type: Full Time, Permanent

    Read full job description

    Capgemini Interview Questions & Tips

    Prepare for Capgemini roles with real interview advice

    Top Capgemini Interview Questions

    Q1. In a dark room,there is a box of 18 white and 5 black gloves. You are allowed to pick one and then you are allowed to keep it and check it o ... read more
    Q2. N-th Fibonacci Number Problem Statement Given an integer ‘N’, your task is to find and return the N’th Fibonacci number using matrix expone ... read more
    Q3. How can you cut a rectangular cake in 8 symmetric pieces in three cuts?
    View all 3k questions

    What people at Capgemini are saying

    What Capgemini employees are saying about work life

    based on 40.6k employees
    71%
    88%
    64%
    85%
    Flexible timing
    Monday to Friday
    No travel
    Day Shift
    View more insights

    Capgemini Benefits

    Submitted by Company
    Salary
    Flexible working
    Leave
    Mobility
    Pension
    Submitted by Employees
    Work From Home
    Cafeteria
    Soft Skill Training
    Health Insurance
    Job Training
    Gymnasium +6 more
    View more benefits

    Compare Capgemini with

    Wipro

    3.7
    Compare

    Accenture

    3.9
    Compare

    Cognizant

    3.8
    Compare

    TCS

    3.7
    Compare

    Infosys

    3.6
    Compare

    Tech Mahindra

    3.5
    Compare

    LTIMindtree

    3.8
    Compare

    Genpact

    3.8
    Compare

    NTT Data Information Processing Services

    4.0
    Compare

    IBM

    4.0
    Compare

    Mphasis

    3.4
    Compare

    Deloitte

    3.8
    Compare

    Google

    4.4
    Compare

    Amazon

    4.1
    Compare

    DXC Technology

    3.7
    Compare

    PwC

    3.4
    Compare

    KPMG India

    3.5
    Compare

    Microsoft Corporation

    4.0
    Compare

    Ernst & Young

    3.4
    Compare

    Bosch Global Software Technologies

    4.0
    Compare

    Similar Jobs for you

    Senior Executive at Piramal Pharma Limited

    Mumbai

    6-10 Yrs

    ₹ 9-13 LPA

    Senior Executive Quality Assurance at Piramal Pharma Limited

    Medak

    5-10 Yrs

    ₹ 8-13 LPA

    Manager Quality Assurance at East African India Overseas

    Dehradun

    12-20 Yrs

    ₹ 10-18 LPA

    Validation Specialist at Amgen Inc.

    Hyderabad / Secunderabad

    5-9 Yrs

    ₹ 14-18 LPA

    Expert at ACODEIDEA TECHNOLOGIES PRIVATE LIMITED

    Coimbatore

    4-10 Yrs

    ₹ 6-12 LPA

    Compliance Specialist at PPD

    Bangalore / Bengaluru

    5-10 Yrs

    ₹ 7-12 LPA

    Compliance Specialist at INVITROGEN BIOSERVICES INDIA PRIVATE LIMITED

    Bangalore / Bengaluru

    4-8 Yrs

    ₹ 5-9 LPA

    System Validation Engineer at Capgemini

    Bangalore / Bengaluru

    3-8 Yrs

    ₹ 8.5-15 LPA

    Automation Tester at Agilisium

    4-8 Yrs

    ₹ 12-21 LPA

    Qa Automation Lead at Staffice Global

    Pune, Chennai + 2

    6-14 Yrs

    ₹ 8-16 LPA

    Capgemini Bangalore / Bengaluru Office Locations

    View all
    Bangalore Office
    Capgemini, Crescent 2, Prestige Shantiniketan, Sadaramanagala Village, Whitefield Main Road Bangalore
    Karnataka 560048
    Bengaluru Office
    Capgemini Business Services (India) Limited, Brigade Metropolis, Summit Tower ‘A’, 73/1, Garudacharpalya, Mahadevapura Post, Whitefield Main Road, Bengaluru Bengaluru
    560 048

    GXP - Computerized System Validation SME

    9-12 Yrs

    Bangalore / Bengaluru

    17hr ago·via naukri.com

    Lead Software Engineer

    5-7 Yrs

    Mumbai

    15hr ago·via naukri.com

    Software Engineer

    2-4 Yrs

    Pune

    15hr ago·via naukri.com

    Senior Software Engineer

    4-6 Yrs

    Bangalore / Bengaluru

    15hr ago·via naukri.com

    Senior Software Engineer

    4-6 Yrs

    Pune

    15hr ago·via naukri.com

    Business Advisor - A

    2-5 Yrs

    Noida

    15hr ago·via naukri.com

    Software Engineer

    2-4 Yrs

    Bangalore / Bengaluru

    15hr ago·via naukri.com

    Business Advisor - A

    2-5 Yrs

    Bangalore / Bengaluru

    16hr ago·via naukri.com

    Record To Analyze Process Expert - B

    3-7 Yrs

    Noida

    16hr ago·via naukri.com

    ECU HW Development Professional

    3-7 Yrs

    Bangalore / Bengaluru

    16hr ago·via naukri.com
    write
    Share an Interview