Katalyst CRO

Validation Engineer

8 months ago

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Responsibilities

Support of creating and maintaining GxP (GMP, GCP, GLP) quality and Perform GxP and 21 CFR part 11 assessments and develop a validation plan.
Develop functional risk strategy and perform functional risk assessment.
Review user business process documents and user requirements specification.
Review functional, technical and configuration design documents.
Prepare and/or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualification (PQ) protocols.
Draft the OQ & PQ test scripts for the GxP requirements and E2E GxP test scenarios.
Support overall protocol executions, log and track defects.
Review the executed test protocols for the proper documentation of test results and evidence.
Review the defects for proper documentation per the checklist.
Prepare and maintain the traceability matrix to ensure all the requirements are covered in design documents and tested.
Prepare and approve qualification summary report.
Support release management activities by reviewing and ensuring the pre-requisites are completed prior to the release.
Review Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI), and training materials.

Requirements

Excellent communication (oral and written) and attention to detail.
Experience in CSV/Validation in Pharmaceuticals or Medical Device domain with experience in managing large global SAP validation projects.
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
Excellent knowledge of computer system validation and GAMP -5 standards.