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Tier-1 employer and metro location increase competition, but niche SAP DMS/GxP skills narrow applicant pool.
Specialized SAP DMS and GxP validation experience is industry-specific and not easily transferable.
Regulatory validation expertise and mandatory SAP DMS technical skills create strict screening and domain filters.
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Manage and configure SAP Document Management System (DMS) including document info records, version/revision control, storage categories, KPro, and ArchiveLink.
Ensure data integrity, secure access, and regulatory compliance through validation deliverables like URS, FS, IQ/OQ/PQ protocols, and Traceability Matrices.
Support integration of DMS with SAP modules such as PP, QM, PM, and MM, focusing on document lifecycle and engineering change management.
Bachelor’s or Master’s degree in Computer Science, Engineering, Applied Mathematics, or related quantitative discipline.
Strong hands-on experience with SAP DMS configuration and validation documentation preparation/review.
In-depth knowledge of GxP regulations, FDA 21 CFR Part 11, EU Annex 11, and data integrity principles.
Work Experience Required: Not explicitly mentioned in the JD.
Experienced in SAP DMS technical configuration combined with compliance-driven validation in regulated industries, preferably life sciences.
Skilled at collaborating with cross-functional teams including business, IT, quality, and regulatory stakeholders.
Detail-oriented with ability to analyze business requirements and translate them into validated document management solutions ensuring audit readiness.