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Validation Engineer

Validation Engineer

Green HR Solutions

0 years

|

0 Lacs

Posted:1 day ago| Platform:

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Skills Required

manufacturing engineering support software compliance installation documentation reports risk analysis regulations training audits

Work Mode

On-site

Job Type

Full Time

Job Description

Validation Engineer

Develop and maintain validation protocols and plans for equipment, processes, software, and systems in compliance with regulatory standards (e.g., FDA, GMP, ISO).
Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Prepare and review validation documentation, including protocols, reports, SOPs, and deviation reports.
Perform risk assessments and root cause analysis to identify and mitigate potential validation issues.
Ensure validation processes meet industry regulations such as FDA 21 CFR Part 11, GxP, ISO standards, and other relevant guidelines.
Work with manufacturing, quality assurance, engineering, and IT teams to ensure validation activities are integrated smoothly into operations.
Recommend and implement improvements to validation processes and protocols.
Provide training to staff on validation procedures and regulatory requirements.
Assist in internal and external audits by providing validation records and explanations.
Assist in internal and external audits by providing validation records and explanations.

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