Quality Management System analyst

at  Thermo Fisher Scientific

HOW WILL YOU MAKE AN IMPACT

Thermo Fisher Scientific Inc. is seeking a highly motivated and experienced Systems Analyst II to join our Information Technology (IT) department in Budapest. This is a unique opportunity to be part of our world-class team, supporting our Quality, Regulatory & Validation Technologies for QMS Systems. As a Systems Analyst II, you will play a crucial role in ensuring flawless operation and optimization of these systems.

EDUCATION

Bachelor’s degree or equivalent previous experience, demonstrating the knowledge, skills, and abilities required to effectively fulfill the role (equivalent experience typically ranging from 2 to 5 years).

EXPERIENCE

• Demonstrated ability in systems analysis or a related role, with a focus on QMS systems.
• Demonstrated experience in handling a multi-lingual and multi-cultural end user support function.
• Experience of working in a regulated environment.
• Experience with GxP regulations (GMP, GLP, GCP), CFR 21 Part 11, and IEC 62443 standards, to implement IT solutions in compliance with the required guidelines.
• Knowledge of Good Manufacturing Practices (GMP), Software Development Lifecycle (SDLC) and Computers Systems Validation (CSV).

KNOWLEDGE, SKILLS, ABILITIES:

• Solid background in Quality Management Systems is desirable i.e. MasterControl, TrackWise Digital (Salesforce).
• Outstanding verbal and written communication skills.
• Experience with system support/system administration.
• Ability to drive multiple initiatives in a fast-paced environment.
• Excellent analytical abilities, creative problem-solving skills, and strong planning and organizing capabilities.
• Experience with validation, training, continuous improvement, corrective and preventive actions (CAPA), and/or supplier audits
• Ability to work well within team environment.
• Project management experience is helpful.
• System integration experience i.e. ERP with MasterControl would be a plus.
• Preferred candidates will have expertise or administration experience in one or more of the following applications: MasterControl, TrackWise Digital, Kneat, SampleManager, HP ALM, WERCS, Veeva, ServiceNow, RIMS, Smartsheet, SharePoint.
  By joining Thermo Fisher Scientific, you will become part of a dynamic and ambitious team that is driven by a shared passion for making the world healthier, cleaner, and safer. We value diversity and believe that different experiences, backgrounds, and perspectives contribute to our success

• Maintains Quality Management system performance and system up-time by performing system monitoring and analysis; resolving system configuration issues; operating and system management; and raising application problems to vendor.
• Handles support tickets through investigation, critical issue, and resolution within established Service Level Agreement (SLA).
• Collaborate with various teams to identify business requirements and convert them into technical solutions.
• Conduct system audits and identify areas for improvement.
• Review changes to validated state of system through the change control and participates in planning and implementing changes.
• Provide end-user support and training on QMS systems.
• Adhere to regulatory and compliance standards.