Data Integrity Compliance Specialist
- Monza
- Tempo indeterminato
- Full time
- 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.
- Bachelor’s Degree in Science, Engineering, or related fields, or equivalent experience.
- 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.
- Minimum 1 years of experience in a regulated industry, or 1 year with relevant technical knowledge.
- Proficiency in English.
- Problem-solving
- Decision-making
- Strong communication, negotiation, and influence skills
- 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