SAP QM Validation Analyst
Job Location:
Piscataway, NJ - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
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
