Senior IT Compliance Specialist

at  Thermo Fisher Scientific

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in computer science or equivalent desireable.
• 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

• 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.
• You Support IT functions identifying issues/risks, performing gap analysis, plan elaboration, definition, and monitoring of the corrective actions.
• 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.
• Maintains and performs 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.