What are the responsibilities and job description for the CSV Engineer position at Katalyst CRO?
Summary
- Mandatory - Validation experience with ERP applications / SAP / MES
- Experience in validating ERP/SAP/ MES Manufacturing applications
- Preferred tools knowledge and experience: JIRA, SAP Solution Manager, XRAY and Change Record review
- Should be experienced in Test scripts, executions and defect reviews.
- Strong verbal and written communication skills.
- Ability to work as a team player, lead a team or accomplish tasks without supervision.
- Ability to work with remote teams and support several changes/projects simultaneously.
- Ability to provide Validation guidance, timely reviews, and escalations to TQ management.
- 3 years' experience with System Development Lifecyle 7 years' experience in Computer System Validation (Based on the role selected)
- Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
- Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation
- Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
- Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
- Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.