CSV (Computer System Validation)Engineer

Cognizant

10 - 14 years

15 - 25 Lacs

hyderabad pune chennai

Posted:-1 days ago| Platform:

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Skills Required

capa change control alm agile deviation computer system validation

Work Mode

Hybrid

Job Type

Full Time

Job Description

Key responsibilities

Develop and execute validation documents:
Create and implement validation plans, test protocols (IQ, OQ), risk assessments, and summary reports.
Ensure regulatory compliance:
Verify that systems meet regulations such as FDA 21 CFR Part 11, GxP, and ISO standards, and align with company policies.
Conduct testing and risk assessments:
Perform system testing to verify performance and conduct risk assessments and impact analyses to identify and mitigate potential issues.
Manage deviations and changes:
Document and remediate deviations found during validation and manage changes to computerized systems.
Collaborate with teams:
Work with cross-functional teams, vendors, and system owners to ensure validation activities are integrated into the system lifecycle.
Provide documentation and support:
Maintain comprehensive validation documentation and support staff with training and knowledge of validation processes.

Essential skills and qualifications

Education:
A bachelor's degree in Computer Science, Information Technology, or a related field is often required.
Experience:
Typically requires several years of experience in computer system validation.
Technical knowledge:
Associate with 8-10 Years of experience in Computer System Validation and with good knowledge on handling Change controls, CAPA and Deviations. Infra Qualification or Veeva vault experience will be a value add. Should have hands-on experience in using ALM and worked on Agile model.
Skills:
Strong technical writing, documentation, communication, and problem-solving skills are essential.
Industry knowledge:
Understanding of systems used in areas like process automation, lab automation, and IT applications is beneficial.

Location- Chennai/Hyderabad/Coimbatore/Pune

Notice Period- 0-30 Days

Note: Please note that your profile would be rejected if your notice period is less than 30 days since we are looking for immediate joiners or do not have the experience in the above mentioned skills.

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