Senior IT Compliance Specialist

1 mese fa

Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
Job Title: Senior IT Compliance Specialist

As a key member of the PSG IT Core Services Team, you will play a crucial role in delivering solutions and support in partnership with local and global functions. Your primary responsibility will be to provide operational compliance and technical support to the site, driving efficient and compliant technology solutions.

Key Responsibilities:
  • 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 corrective actions
  • IT point of contact (POC) supporting project activities conducted by the CSV team and for new manufacturing lines, digital performance management, Industry (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 business requirements, technology needs, 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
Requirements:
  • 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 and 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 relationship
  • 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. At Thermo Fisher Scientific, 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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