Global IT Validation & Compliance Expert

Curium Pharma; Schagen; On-site; EUR 54,730 - 80,366; Full time

Benefits offered by this job

Holiday allowance

13th month salary

Bonus scheme

Job summary

A global healthcare company based in Schagen is seeking a Global IT Infrastructure CSV/CSA Expert to ensure the reliability and compliance of IT systems in the healthcare sector. The role involves preparing validation documentation, conducting audits, and training colleagues on compliance standards. A bachelor's degree in IT or a related field and several years of experience in IT compliance and data integrity is required. The position offers a competitive salary and the opportunity to impact patient safety globally.

Qualifications

• Several years of experience in CSV/CSA, data integrity, and IT compliance.
• Knowledge of GxP, EU Annex 11, 21 CFR Part 11.
• Understanding of IT infrastructure including cloud and data flows.
• Fluent in English; Dutch is important for local communication.

Responsibilities

• Prepare and execute validation and qualification documentation.
• Perform risk-based analyses for IT compliance.
• Ensure compliance with FDA and EU regulations.
• Conduct internal and external audits and inspections.
• Train global IT colleagues on compliance procedures.

Skills

CSV/CSA

Data integrity

IT compliance

Strong communication skills

Curiosity about technology

Education

Bachelor’s degree in IT, Engineering, Computer Science, or Life Sciences

Job description

A global healthcare company based in Schagen is seeking a Global IT Infrastructure CSV/CSA Expert to ensure the reliability and compliance of IT systems in the healthcare sector. The role involves preparing validation documentation, conducting audits, and training colleagues on compliance standards. A bachelor's degree in IT or a related field and several years of experience in IT compliance and data integrity is required. The position offers a competitive salary and the opportunity to impact patient safety globally.