Job Description
- Listing below is the major R&R for this position for your quick reference:-
- Need BA to support R&D PLM implementation and Quality Systems LIMS, IQVIA .
- Responsible for executing project activities and author/produce System Development Life Cycle (SDLC) deliverables as defined in the Validation Plan or as outlined in the project Deliverables List, applicable BD methodologies, standards, and Good Documentation Practices (GxP).
- Provides input to the requirements, risk assessments, system design, testing approach, traceability, and other documentation.
- Business Analyst is expected to work in collaboration with other project team members including Business Partner, Project Manager, Technical Lead, Technical SMEs, Business SMEs, Test Lead, Testers, and Validation Lead.
- Develop/author Regulatory Impact Assessment, User Requirements Specification, Functional Requirements Specification, and Traceability Matrix.
- Contribute to development of Regulatory Applicability Assessment, Information Security Risk Assessment & Management Plan, Data Privacy Assessment & Risk Management, Vendor Audit Checklist and Report, 21 CFR Part 11 Assessment, Design Review Summary Report, Functional Risk Assessment Report, Validation Plan, System Design Specification (Architecture and Software), IQ/OQ/PQ Test Plan and Test Scripts, Data Migration Plan, Validation Summary Report, Periodic Review Report, Decommissioning Plan, and Decommissioning Report.
Mandatory skills: Teamcenter (Integration and Data Migration) and LIMS for Quality.
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