SAP Business Analyst with PLM Teamcenter, $70 on W2 only, Remote Position.
Posted 3 days ago by FASTRA LLC
Negotiable
Undetermined
Remote
Remote
Summary: The role of SAP Business Analyst focuses on supporting R&D PLM implementation and Quality Systems, specifically LIMS and IQVIA. The position requires collaboration with various project team members to execute project activities and produce necessary documentation as per defined methodologies and standards. The analyst will also be responsible for developing regulatory assessments and specifications related to system design and validation. This is a remote position with a specific emphasis on mandatory skills in Teamcenter and LIMS for Quality.
Key Responsibilities:
- 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.
Key Skills:
- Teamcenter (Integration and Data Migration)
- LIMS for Quality
Salary (Rate): £70 hourly
City: undetermined
Country: undetermined
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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.