Job Description

Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeAbout Us: Join Thermo Fisher Scientific and be part of a team that values performance, quality, and innovation. With over $40 billion in revenue and the largest R&D investment in the industry, we provide the resources and challenges to make significant contributions to the world.How You Will Make an Impact: Thermo Fisher Scientific is seeking a motivated and experienced Systems Analyst II to join our IT department in Bangalore, India. You will support our Quality, Regulatory & Validation Technologies for QMS Systems, ensuring flawless operation and optimization.Key Responsibilities:

• Maintain Quality Management System performance and uptime through monitoring, analysis, and resolving system issues.
• Manage end-user support tickets, ensuring timely resolution within established Service Level Agreements (SLAs).
• Collaborate with teams to identify business requirements and translate them into technical solutions.
• Conduct system audits to identify areas for improvement.
• Review and implement changes to the validated state of systems through change control processes.
• Provide end-user support and training on QMS systems.
• Adhere to regulatory and compliance standards.

• Bachelor's degree or equivalent experience (2 to 5 years).

• Proven ability in systems analysis or a related role, focusing on QMS systems.
• Experience managing multi-lingual and multi-cultural end-user support.
• Experience in regulated environments.
• Familiarity with GxP regulations (GMP, GLP, GCP), CFR 21 Part 11, and IEC 62443 standards.
• Knowledge of Good Manufacturing Practices (GMP), Software Development Lifecycle (SDLC), and Computer Systems Validation (CSV).
• Salesforce Admin Beginner Certification in Trailhead.
• Familiar with middleware integration tools like MuleSoft, Oracle Fusion Middleware (OFM) and Informatica.

• Experience maintaining and implementing Quality Management Systems applications (e.g., MasterControl, TrackWise Digital, Veeva).
• Excellent verbal and written communication skills.
• Experience with system support and administration.
• Ability to manage multiple initiatives in a fast-paced environment.
• Strong analytical, problem-solving, and planning skills.
• Experience with validation, training, change management, CAPA, and supplier audits.
• Ability to work effectively in a team environment.
• Project management experience is a plus.
• System integration experience (e.g., ERP with MasterControl) is a plus.
• Preferred expertise or administration experience in applications such as MasterControl, TrackWise Digital, Kneat, SampleManager, HP ALM, WERCS, Veeva, ServiceNow, RegDesk RIMS, Smartsheet, and SharePoint.

Thermo Fisher Scientific