Job Description
MXOPS
KEY RESPONSIBILITIES
Lead and execute SAP validation activities, ensuring compliance with CSV, SDLC, GMP, and applicable regulatory requirements.
Develop, review, and maintain validation documentation, including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, IQ/OQ protocols, Traceability Matrices, and Final Reports.
Collaborate with IT, Quality, Manufacturing, Supply Chain, and Business stakeholders to ensure successful deployment and validation of SAP solutions.
Manage deviations, discrepancies, CAPAs, and change control activities associated with SAP implementations.
Utilize tools such as JIRA, ALM, Azure DevOps, Solution Manager, or equivalent platforms to manage testing and validation activities.
Support audits and inspections by providing validation evidence and ensuring compliance with FDA, GxP, and company quality standards.
Provide technical guidance and mentorship to junior va...