Job Summary
• Location: Northeast US
• Experience: 3+ years in SAP QM
• Job Type: Contract (6-9 months)
Thinking Minds' client is looking for an experienced SAP QM Validation Analyst to support the validation of their Quality Management System and SAP implementation. This role is crucial for ensuring compliance with regulatory standards like 21 CFR Part 11 and GxP. The analyst will work closely with Quality, IT, and business functions to deliver validation artifacts and maintain the validated state of systems.
Ideal Candidate Should Have
• SAP QM experience
• MasterControl QMS exposure
• Experience with 21 CFR Part 11
• Familiarity with GAMP 5 principles
• Experience in a GxP-regulated environment
Role Overview
The role involves supporting the validation of the MasterControl QMS and SAP modules such as QM, MM, and PP. The analyst will author and execute validation protocols, contribute to risk assessments, and ensure compliance with regulatory standards. Collaboration with QA, IT, and business process owners is essential for successful implementation and maintenance of validated systems.
Key Responsibilities
• Support validation of MasterControl QMS
• Author and execute IQ/OQ/PQ protocols
• Validate SAP QM, MM, PP modules
• Conduct risk assessments and data integrity evaluations
• Liaise with QA, IT, and external partners
• Maintain validated state of systems
Top Skills and Modules
• SAP QM
• MasterControl QMS
• 21 CFR Part 11
• GAMP 5 principles
• Data integrity (ALCOA+)
• SAP MM
• SAP PP
• Risk-based validation