US Citizen
Green Card
EAD (OPT/CPT/GC/H4)
H1B Work Permit
Corp-Corp
W2-Permanent
W2-Contract
Contract to Hire
Consulting/Contract
UG :- - Not Required
PG :- - Not Required
No of position :- ( 1 )
Post :- 20th Feb 2024
This role is designed to provide integration services between solution architects, the business and project management while maintaining deep understanding of the business from a technical lens and knowledge of schedule & resource allocation. Responsible for ensuring that the business processes embedded across businesses, functions or regions are integrated and aligned with and capable of executing the strategy on a global basis. This role is focused on process design and process integration from technology standpoint.
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 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
Experience in producing quality deliverables per System Development Life Cycle (SDLC) methodology
Experience working in GxP-regulated Computer Systems Validation (CSV) including 21 CFR Part 11 is required
Experience / domain expertise in Life Sciences / Medical Device industry is required
Experience working in Product Lifecycle Management (PLM) implementation, upgrade, migration programs/projects is required
Functional knowledge of foundational PLM capabilities like Part/CAD/BOM Management, Document Management, Design Control (DHFs/DMRs), Requirements and Risk Management, Configuration/Variant Management, and Change Management is required
Experience in Siemens Teamcenter is preferred
Experience working in Application Lifecycle Management (ALM) implementation projects and tools like Siemens Polarion is preferred.