Capgemini

Computer system Validation I 6 to 12years I Hyderabad I

Posted On

Dec. 12, 2024

Location

Bangalore, Karnataka

Experience Level

Experienced Professionals

Job Type

Permanent

Apply By

Feb. 5, 2025

Job Description

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities, collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow. Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose.

Job Description

Mandatory Skills: (Must Have Skills) ITIL knowledge, GxP knowledge, System Life Cycle, GxP CSV Documentation
Optional Skills: (Good to Have Skills) Strong communication skills, Virtual global IT operation.
Roles & Responsibilities: System management support responsible to manage documentations, year wheel activities and support for user requests/queries.
Work closely with the Global stakeholders

Primary skills

Develop and execute validation plans for computerized systems.
Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
Conduct risk assessments and gap analysis to identify validation needs.
Create and maintain detailed documentation for validation activities.
Review and approve system lifecycle documents including requirements, design, and test protocols.
Ensure adherence to good documentation practices (GDP).
Monitor and report on validation project status and results.
Support regulatory audits and inspections as the subject matter expert on CSV.

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.

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Job Description

Job Description

Primary skills

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