Data Integrity Compliance Specialist
Data Integrity Compliance Specialist
Posted on :
26-07-2025
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1 Vacancy
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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:
- Bachelors 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!
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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