Job Description

Job Summary

• Need a Senior resource who has Computer System Validation knowledge and work experience.
• Should have ERP knowledge and experience, preferably SAP ECC or SAP S4 HANA.
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation; Define and implement Risk based validation activities.
• 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.
• Preferred tools knowledge and experience JIRA, SAP Solution Manager, XRAY
• Should be experienced in Test scripts, executions and defect reviews.
• Should be experienced in change control reviews
• Ability to work with remote teams and support several changes/projects simultaneously.

Ability to provide Validation guidance, timely reviews, and escalations.

Key Responsibilities

• Need a Senior resource who has Computer System Validation knowledge and work experience.
• Should have ERP knowledge and experience, preferably SAP ECC or SAP S4 HANA.
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation; Define and implement Risk based validation activities.
• 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.
• Preferred tools knowledge and experience JIRA, SAP Solution Manager, XRAY
• Should be experienced in Test scripts, executions and defect reviews.
• Should be experienced in change control reviews
• Ability to work with remote teams and support several changes/projects simultaneously.

Ability to provide Validation guidance, timely reviews, and escalations.

Skill Requirements

Other Requirements