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: Bachelors or masters 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.