Data Integrity Compliance Specialist

Work Schedule

Environmental Conditions

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!