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Quality Management System analyst

AT Thermo Fisher Scientific
Thermo Fisher Scientific

Quality Management System analyst

Budapest, Hungary

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Job Title! Systems Analyst II

When you join us at Thermo Fisher Scientific, you'll do ambitious work, and be part of a team that values performance, quality, and innovation. Within this successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we provide our people the resources and challenges to deliver significant contributions to the world!

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.

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Key Responsibilities:

  • 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.

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.

Client-provided location(s): Budapest, Hungary
Job ID: ThermoFisher-R-01269568-3
Employment Type: Full Time

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • FSA
    • HSA
    • HSA With Employer Contribution
    • Mental Health Benefits
    • Fitness Subsidies
  • Parental Benefits

    • Adoption Leave
    • Birth Parent or Maternity Leave
    • Non-Birth Parent or Paternity Leave
    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
  • Work Flexibility

    • Flexible Work Hours
    • Hybrid Work Opportunities
    • Remote Work Opportunities
  • Office Life and Perks

    • Commuter Benefits Program
    • On-Site Cafeteria
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Volunteer Time Off
  • Financial and Retirement

    • 401(K) With Company Matching
    • Stock Purchase Program
    • Financial Counseling
    • Performance Bonus
  • Professional Development

    • Tuition Reimbursement
    • Access to Online Courses
    • Internship Program
    • Mentor Program
  • Diversity and Inclusion

    • Employee Resource Groups (ERG)
    • Diversity, Equity, and Inclusion Program