Senior IT Compliance Specialist

2 giorni fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Senior IT Compliance Specialist

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 $24 billion and the largest investment in R&D in the industry, we provide our people the resources and challenges to deliver meaningful contributions to the world.

How will you make an impact?

As a member of the PSG IT Core Services Team delivering solutions & support in partnership with local and global functions, we will provide operational compliance and technical support to the site driving efficient and compliant technology solutions.

What will you do?

  • Be the Key contact to ensure operational compliance of IT.
  • Collaborate with global teams to align, develop and implement IT processes, policies, procedures and documentation to meet industry standards, regulatory, business and quality requirements.
  • Support IT functions identifying issues/risks, performing gap analysis, plan elaboration, definition, and monitoring of the corrective actions.
  • Act as IT point of contact (POC) supporting project activities conducted by the CSV team and for new manufacturing lines, digital performance management, Industry 4.0 (Rockwell Factory Talk).
  • Ensure IT systems are maintained in GxP validated state for intended purpose.
  • Drive the execution of smaller projects within scope, budget, and schedule by developing and completing project documentation to support the business requirement, technology need and regulations.
  • Support site audit readiness and regulatory inspections, and client audits.
  • Support crafting and handling deviations, CAPAs and Change Controls.
  • Maintain and perform periodic user reviews of main IT systems, updates, and refresh of IT operating procedures in collaboration with IT technical/application group, CSV, and quality team.
  • Guide the periodic discussion on IT internal metrics sharing and Key Performance Indicator monitoring.

How will you get here?

Education and Experience:

  • Bachelor’s degree in computer science or equivalent desirable.
  • 3+ years of relevant, IT related work experience.
  • Previous experience working in an IT compliance role.
  • Experience working onsite in a customer-facing role providing technical support.
  • Experience working with EDMS and QMS systems writing changes, deviations, CAPAs.
  • Experience writing test plans, designs, business processes, requirements, technical specifications.
  • Experience in working with IT colleagues across various geographies and disciplines.

Knowledge, Skills, Abilities

  • Solid grasp of IT Controls, GAMP5, GxP regulations, CSV, SDLC, Data Integrity, Part 11, Annex11, and relevant standards.
  • Strong analytical, prioritization, problem-solving, time management and organization skills.
  • Excellent written, verbal communication and interpersonal skills to effectively collaborate with multi-functional global/local teams and end-users.
  • Ability to handle customer and supplier management relationships.
  • Shown flexibility to balance and prioritize numerous tasks.
  • Drive and desire to learn and grow both technical and functional skills.
  • ITIL Foundations Certification is a plus.

Our 4i Values:

As one team of 125,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, tackle complex scientific challenges, drive technological innovation, and support patients in need #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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