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-solvingDecision-makingStrong communication, negotiation, and influence skills

Proficiencies:Excellent communication skillsAbility to make quality decisions by calculating risks and understanding their impactsCollaborationData Management and analytical skillsCapability to manage multiple tasks simultaneously

Join us and be part of an exceptionally ambitious team working towards competing and successfully implementing world-class standards!