Job Information
ThermoFisher Scientific Data Integrity Compliance Specialist in Monza, Italy
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Thermo Fisher Scientific Inc. as a Data Integrity Compliance Specialist to uphold Data Integrity principles.
Specific responsibilities/main activities
Ensure all equipment and systems are strictly evaluated for use in line with Data Integrity, 21CFR Part 11, and Annex 11 principles.
Conduct Data Integrity Risk Assessments on systems and processes, communicating gaps to respective areas and ensuring timely implementation of CAPAs.
Deliver periodic training to improve site awareness and culture on Data Integrity topics.
Follow the surveillance program for all GMP areas, manage critical metrics, share results with the proactive quality manager, and suggest improvement actions.
Review Data Integrity-related events to ensure CAPAs are effectively structured to prevent recurrence.
Support GAP assessments to align data integrity processes with corporate policies.
Facilitate quality continuous improvement projects, both locally and globally.
Review change controls, SOPs, URS, and other GMP documents impacting Data Integrity.
Participate in departmental Data Integrity huddles.
Provide support during Client and Regulatory Audits.
Requirements
Education:
- Bachelor’s Degree in Science, Engineering, or related fields, or equivalent experience.
Technical Skills:
Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
Experience with 21CFR Part 11 and Annex 11.
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
Basic knowledge of system architecture and automation.
Professional Experience:
- Minimum 1 years of experience in a regulated industry, or 1 year with relevant technical knowledge.
Foreign Languages:
- Proficiency in English.
Personality Traits:
Problem-solving
Decision-making
Strong communication, negotiation, and influence skills
Proficiencies:
Excellent communication skills
Ability to make quality decisions by calculating risks and understanding their impacts
Collaboration
Data Management and analytical skills
Capability to manage multiple tasks simultaneously
Join us and be part of an exceptionally ambitious team working towards competing and successfully implementing world-class standards!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.