Job Title:  Consultant | SAP DMS (Document Management System) | Noida | SAP | DSA LS&HC

Consultant | SAP DMS (Document Management System) |  SAP | DSA LS&HC

Location : Noida

Key responsibility: 

• Core Functions: Manages document info records (DIR), controls document versions/revisions, and automates the distribution of documents to modules like PP (Production Planning) or QM (Quality Management).
• Business Benefits: Minimizes data redundancy, centralizes storage, and streamlines role-based access to vital corporate information.
• Consultant Role: A DMS consultant maps document types, configures storage categories, manages KPro (Knowledge Provider) and ArchiveLink, and establishes virtual copies of documents.
• Core Functions: Ensures data integrity, accurate audit trails, and secure electronic signatures.
• Business Benefits: Mitigates the risk of non-compliance, prevents costly regulatory penalties, and guarantees patient safety in life sciences.
• Consultant Role: A CSV consultant authors and reviews critical validation deliverables, including User Requirements Specifications (URS), Functional Specifications (FS), Installation/Operational/Performance Qualification (IQ/OQ/PQ) protocols, and Traceability Matrices. 
• Shift Time : 11 AM to 8 PM

Key Skills Required: 

• Education: Bachelor’s or master’s degree in computer science, Engineering, Applied Mathematics, or a related quantitative discipline.
• Strong knowledge of SAP DMS configuration, including Document Info Records (DIR), document types, version and revision management.
• Experience in configuring storage categories, KPro (Knowledge Provider), ArchiveLink, and content repositories.
• Understanding of document distribution and integration with SAP modules such as PP (Production Planning), QM (Quality Management), PM, and MM.
• Familiarity with document lifecycle management, engineering change management, and virtual document structures.
• Knowledge of authorization concepts, role-based access control, and document security.
• Ability to analyze business requirements and design efficient document management solutions.
• Strong troubleshooting, testing, and user support skills.

• In-depth understanding of GxP regulations, FDA 21 CFR Part 11, EU Annex 11, and data integrity principles.
• Experience in preparing and reviewing validation documentation, including User Requirements Specifications (URS), Functional Specifications (FS), IQ/OQ/PQ protocols, Validation Plans, and Traceability Matrices.
• Knowledge of risk-based validation methodologies and validation lifecycle management.
• Familiarity with electronic records, electronic signatures, audit trails, and compliance requirements.
• Strong documentation, analytical, and quality assurance skills.
• Experience collaborating with business, IT, quality, and regulatory stakeholders during validation activities.
• Ability to identify compliance gaps, support audits, and ensure validated system maintenance through change control and periodic review.