• 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.