Computerized System Validation Subject Matter Expert

Capgemini Technology Services India Limited

Bengaluru/Bangalore

Not disclosed

Work from Office

Full Time

Min. 9 years

Job Details

Job Description

GXP - Computerized System Validation SME | 9 to 12 years | Bangalore

Choosing Capgemini means choosing a company where you will be empowered to shape your career in the way youd like, where youll be supported and inspired bya collaborative community of colleagues around the world, and where youll be able to reimagine whats possible. Join us and help the worlds leading organizationsunlock the value of technology and build a more sustainable, more inclusive world.

Job Description

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

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fuelled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of 22.5 billion.