Validation Lead

ID4 Consultancy

5 - 8 years

0 Lacs

Pune Maharashtra India

Posted:19 hours ago| Platform:

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Skills Required

risk assessment development support documentation test traceability compliance

Work Mode

On-site

Job Type

Full Time

Job Description

Validation Lead

Responsibilities:

Create, review, and execute validation protocols in accordance with GxP guidelines.
Integrate functional risk assessment results into the OQ protocol development process to identify critical functionalities and potential points of failure.
Should have awareness of system risk level assessments to determine the impact of identified risks on the overall validated system.
Support to maintain validation documentation, such as validation plans, test scripts, and traceability matrices, to demonstrate compliance with regulatory requirements
Identify, log, and track defects, collaborate with development teams for resolution
strong in basics of SQLs

Skill: GxP Validation, GAMP, GDP, 21 CFR Part 11

Relevant Experience: 5 to 8 years

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