SAP QM Validation Analyst

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

Master Control 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 Master Control 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 Master Control 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

Master Control QMS

21 CFR Part 11

GAMP 5 principles

Data integrity (ALCOA+)

SAP MM

SAP PP

Risk-based validation