Data Integrity Consultant: 21 CFR Part 11
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Trevalco is seeking a data integrity consultant to join our pharmaceutical client projects. You will assess systems for compliance with 21CFR Part 11, Eudralex annex 11, and internal requirements, identify gaps, and draft action plans.
The role requires English and Dutch fluency, strong analytical skills, and experience in ICT quality assurance within pharma. You will work independently, balance quality, budget, and schedule, and support risk assessments and quality investigations.
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Data Integrity Consultant
Il y a 3 jours
Antwerpen, Antwerpen, Belgique Trevalco Temps plein 60 000 € - 90 000 € ContratData integrity remains a hot topic in the pharmaceutical industry. Pharmaceutical companies rely on consultants to provide the necessary knowledge and insights to ensure that their systems comply with the latest regulatory requirements. A job as data integrity consultant requires detailed knowledge of the applicable regulations, good skills in technical...
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Pharma Data Integrity
Il y a 3 jours
Antwerpen, Antwerpen, Belgique Trevalco Temps plein 60 000 € - 90 000 € ContratTrevalco is seeking a data integrity consultant to perform assessments ensuring compliance with 21 CFR Part 11, Eudralex Annex 11, and client requirements in the pharmaceutical sector. You will identify non-compliance, draw up action plans, and contribute to improvement projects.You will collect information from people, archives and systems, maintain quality...
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OT Project Manager
Il y a 3 jours
Antwerpen, Antwerpen, Belgique Enginity Temps plein 90 000 € - 130 000 € ContratAls Senior Project Manager Automation & OT speel je een sleutelrol in een strategisch programma rond de scheiding van IT- en OT-netwerken binnen een farmaceutische productieomgeving. De opdracht combineert projectmanagement, OT-expertise en stakeholdermanagement met een sterke focus op operationele betrouwbaarheid, cybersecurity en schaalbaarheid.Vanaf de...
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Computer System Validation
Il y a 1 semaine
Antwerpen, Antwerpen, Belgique Pauwels Consulting Temps plein 65 000 € - 90 000 € ContratOur client, a leading organization in the life sciences sector, is seeking a professional to support computer system validation activities. The role focuses on ensuring that computerized and automated systems in GxP-regulated environments are fit for purpose and comply with both regulatory requirements and internal standards.Draft comprehensive validation...
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Recipe Editor – Siemens Opcenter Pharma
Il y a 17 heures
Antwerpen, Belgium Ag Solution Temps pleinRole OverviewWe are seeking a detail-oriented and technically skilled Recipe Editor with hands-on experience in pharmaceutical manufacturing execution systems to join our team fully remote anywhere within the EU. This role sits at the heart of our MES practice, combining deep expertise in electronic batch record (EBR) design and master batch record (MBR)...
