Validation Engineer
Location: [Not specified]
Experience Required: Prior experience in Validation is mandatory
Job Type: Full-Time
Job Overview:
We are currently seeking a Validation Engineer to join our team. The ideal candidate will be responsible for authoring and executing Operational Qualification (OQ) and Performance Qualification (PQ) test scripts in alignment with functional requirements. This role is essential to ensure that systems are validated in compliance with regulatory and quality standards.
Key Responsibilities:
Documentation & Test Script Development:
Thoroughly understand User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
Author OQ/PQ test scripts based on the functional requirements and ensure traceability.
Execution & Defect Reporting:
Conduct dry runs to identify and document any defects in the scripts or system.
Revise and incorporate review comments or test script errors, and prepare OQ scripts for pre-approval.
Carry out formal OQ executions after approval and raise defects, if identified.
Defect Management:
Follow a structured defect management process to log and track issues.
Re-execute test cases as required based on defect resolution.
Desirable Skills and Experience:
Experience in Validation processes (mandatory).
Familiarity with GxP environments and regulatory expectations.
Good understanding of test script development, execution, and documentation protocols.
Experience with defect tracking tools and quality management systems is a plus.
Strong attention to detail, documentation accuracy, and communication skills.
Estimated Salary: ₹5 LPA – ₹9 LPA (depending on experience and industry sector)
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