IT Quality & Compliance Specialist – GxP & GAMP 5

Pauwels Consulting; Geel; Sur place; EUR 67 000 - 100 000; Plein temps

Résumé du poste

Pauwels Consulting in Geel, Belgium, seeks a specialist to bridge IT and Quality Assurance in the life sciences sector. You will lead audits, manage CAPA, and supervise document control to ensure GxP compliance across IT systems.

The role requires 5+ years in IT quality or compliance within pharma, with deep knowledge of EU GMP Annex 11, 21 CFR Part 11, and GAMP 5. Fluent Dutch and English are essential, onsite five days per week.

Qualifications

• 5+ years in IT quality or compliance within pharmaceutical or life sciences.
• Strong knowledge of EU GMP Annex 11, 21 CFR Part 11, and GAMP 5.
• Proven experience in audit management, CAPA handling, and drafting regulatory procedures.
• Experience with ALCOA+ data integrity and IT validation.
• Bachelor's or Master's in IT, bio-sciences, or related field.
• Fluent in Dutch and English; independent and strong communicator.

Responsabilités

• Lead internal and external audits and inspections while monitoring closure of findings.
• Execute root cause analyses for IT deviations and manage the end-to-end CAPA process.
• Maintain and update SOPs and GOPs to ensure regulatory alignment.
• Evaluate IT changes for GxP impact and oversee documentation accuracy.
• Ensure data integrity across systems following ALCOA+ and support validation.
• Identify process gaps and drive continuous improvement within compliance.
• Act as the primary contact for compliance inquiries from IT teams.

Connaissances

Audit management

CAPA handling

Data integrity (ALCOA+)

IT system validation

Regulatory knowledge

Communication skills

Dutch & English fluency

Formation

Bachelor's or Master's in IT, bio-sciences, or related field

Outils

Quality management systems

SOP/GOP management

Description du poste

Our client, a prominent organization in the life sciences sector, is looking for a specialist to bridge the gap between IT and Quality Assurance. The role involves ensuring IT systems and processes remain compliant with GxP regulations through audit leadership, CAPA management, and document control.

• Prepare and lead internal and external audits and inspections while monitoring the closure of findings.
• Execute root cause analyses for IT deviations and manage the end-to-end CAPA process.
• Maintain and update Standard Operating Procedures (SOPs) and General Operating Procedures (GOPs) to ensure regulatory alignment.
• Evaluate IT changes for GxP impact and oversee the accuracy of technical documentation.
• Ensure data integrity across systems following ALCOA+ principles and support validation activities.
• Identify process gaps and drive continuous improvement initiatives within the compliance framework.
• Act as the primary point of contact for compliance-related inquiries from IT teams.

• You have 5+ years of experience in IT quality or compliance specifically within the pharmaceutical or life sciences industry.
• You possess deep knowledge of EU GMP Annex 11, 21 CFR Part 11, and GAMP 5.
• You bring proven experience in audit management, CAPA handling, and drafting regulatory procedures.
• You have expertise in data integrity standards (ALCOA+) and IT system validation.
• You possess a Bachelor or Master degree in IT, Bio-sciences, or a relevant scientific field.
• You're independent, pragmatic, and possess strong communication skills.
• You are fluent in Dutch and English.

Nice to Haves

• Previous experience with large-scale IT change management in regulated environments.

• Start date: ASAP
• Duration: 6 months (plus extension)
• Work regime: Full-time
• Location: Geel
• Working model: Onsite (5 days per week)
• Contract: open to both permanent employees and freelancers