Related skills
data integrity csv computer system validation risk assessments gamp📋 Description
- Cooperate with multifunctional teams to assess local systems and equipment.
- Define risks and vulnerabilities for the local systems and equipment.
- Provide Data Integrity guidance and support towards local Subject Matter Experts.
- Define remediation activities and create Data Integrity plans.
- Act as local Process Owner for Data Integrity.
- Prepare for audits and inspections by regulatory agencies and customers.
🎯 Requirements
- Master scientific degree or equivalent experience.
- 3 years’ experience in the pharmaceutical industry.
- Knowledge of cGMP/CSV compliance (21 CFR 11, EU directives).
- Strong ownership and quality mindset; deliver on commitments.
- Experience with Data Integrity remediation activities.
- Fluent in English and Dutch.
🎁 Benefits
- Hybrid work arrangement with 2 days WFH per week.
- Global CRO environment with sponsor collaboration.
- Professional development and audits exposure.
- Involvement with the Data Integrity Community of Practice.
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