Summary of Position:
The Business Analyst supports laboratory IT systems used in a Medical Devices environment. This role works with IT Project Manager, to collaborate with site SME and vendors to deliver support systems such as LABVANTAGE LIMS, Waters Empower, and Veeva. The position focuses on understanding business needs, coordinating projects, managing vendors, and supporting procurement activities, while ensuring compliance with Medical Device regulations.
Key Responsibilities:
Business Interaction & Requirement Analysis
- Work closely with laboratory teams (QC, QA, R&D, Manufacturing Support) to understand their daily processes and system needs.
- Gather, document, and confirm business requirements in clear and simple language.
- Translate user needs into functional requirements for LABVANTAGE LIMS, Empower, and Veeva systems.
- Support change requests, enhancements, and system improvements.
- Ensure requirements meet Medical Device quality and compliance expectations.
Project Coordination
- Coordinate project activities between Site SMEs, IT DevOps teams, and external vendors.
- Support project planning, timelines, and regular status updates.
- Organize and facilitate requirement discussions, design reviews, and UAT sessions.
- Track actions, risks, issues, and dependencies to keep projects on track.
- Support system implementations, upgrades, and stabilization activities.
Vendor Management
- Act as the main point of contact for software vendors and service partners.
- Coordinate vendor meetings, deliverables, and timelines.
- Review vendor proposals, estimates, and statements of work (SOWs).
- Help resolve vendor-related issues and follow up on commitments.
Procurement, Purchase Orders & Invoices
- Support the creation and tracking of Purchase Orders (POs).
- Coordinate with procurement, finance, and vendors for invoice processing.
- Check invoices against contracts and delivered work before approval.
- Track project costs and support budget monitoring.
Compliance & Documentation (Medical Devices Focus)
- Support system validation activities following Medical Device regulations.
- Assist with documentation such as URS, functional specs, test scripts, and traceability.
- Ensure systems meet data integrity, 21 CFR Part 11, and ISO 13485 requirements.
- Maintain accurate and up-to-date system and project documentation.
Key Requirements/Minimum Qualifications:
- 1-5 years of experience as a Business Analyst supporting LIMS or laboratory systems.
- Hands-on experience with LABVANTAGE LIMS, Waters Empower, and/or Veeva.
- Strong communication skills and the ability to work with both technical and non-technical users.
- Experience working in a Medical Devices regulated environment.
- Work closely with stakeholders to support defining the scope and document integrations requirements with other QRA applications and systems.
- Understanding of AI capabilities and the ability to analyze and translate AI-driven use cases into business requirements.
- Understanding system validation, audits, and quality processes.
- Experience with vendor coordination and procurement activities (POs and invoices).
- Good organization and coordination skills.
Preferred Qualifications
- Bachelor’s degree in Life Sciences, Engineering, IT, or a related field.
- Familiarity with laboratory workflows such as sample management, testing, and results review.
- Experience supporting audits and inspections.
- Business Analysis or Project Management certification is a plus.
Work hours: 1 PM to 10 PM IST
Relocation assistance: Yes
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