الوصف الوظيفي
Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAbout 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. Education:Bachelor's degree or equivalent experience (2 to 5 years). Experience: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. Knowledge, Skills, and Abilities: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.
