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Prodapt Solutions
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Validation Engineer / DIS / DEA

Validation Engineer / DIS / DEA

Prodapt Solutions

5 - 10 years

|

3 - 6 Lacs

Posted:1 day ago| Platform:

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Skills Required

sql queries dis sql quality check complex sql query oracle performance tuning indexing data validation sql tuning packaging triggers t-sql sql server stored procedures plsql database design collections ssrs debugging

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Summary:

Validation Engineer

Key Responsibilities:

Plan, execute, and manage
validation activities
for automated systems, laboratory instruments, and manufacturing equipment.
Prepare and maintain
validation documentation
including URS, IQ, OQ, PQ, and traceability matrices.
Ensure
compliance with GxP, 21 CFR Part 11, Annex 11, and Data Integrity
requirements.
Collaborate with
cross-functional teams
to support DIS (Data Integrity Systems) and DEA (Design & Engineering Automation) processes.
Conduct
risk assessments, change controls, and deviation investigations
related to validated systems.
Support
computer system validation (CSV)
activities for new and existing software/hardware.
Participate in
audit preparation and regulatory inspections
by providing validation documentation and support.
Maintain up-to-date knowledge of industry best practices and regulatory expectations related to validation and data integrity.

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Prodapt Solutions

Software Development

Chennai Tamilnadu

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