CSV & Data Integrity Lead – Regulatory Risk Defender

Nalys; Wallonië; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Nalys is seeking a CSV & Data Integrity Lead to join a remediation program at a leading Belgian pharmaceutical site in Brabant wallon. You will reassess data integrity gaps, validate gap closures, and build a defensible risk picture to guide remediation or replacement decisions.

Reporting to the program lead, you will collaborate with quality, engineering, and IT/OT teams, challenge past conclusions with rigor, and document technical justifications for management sign-off.

Qualifications

• Master's degree in engineering, pharmacy, life sciences, or a related field.
• Minimum of 5 years' CSV/Data Integrity experience in GMP environments.
• Fluent with GAMP 5, 21 CFR Part 11, EU GMP Annex 11, and ALCOA+.
• Hands-on experience with data integrity risk assessments on production equipment.
• Experience in regulatory inspections or internal audits (FDA, EMA, or national authorities).
• Strong documentation and ability to challenge conclusions with rigor.

Responsabilités

• Reviewing and revalidating CSV/Data Integrity assessments against current regulatory expectations.
• Reassessing gaps (access management, shared accounts, backup/restore, audit trail) and their criticality.
• Structuring findings by equipment family for scalable remediation.
• Defining mitigation, partial remediation, or full replacement per a 'mitigate first' approach.
• Documenting residual risk and technical justification for recommendations.
• Contributing to a risk-based model applicable across a broader equipment population.
• Liaising with quality, engineering, and IT/OT for sign-off and validation.
• Supporting management-ready deliverables for the program.

Connaissances

CSV/Data Integrity experience

GAMP 5

21 CFR Part 11

EU GMP Annex 11

ALCOA+ principles

Regulatory inspections exposure

English & French communication

Formation

Master's degree in engineering, pharmacy, life sciences, or related field

Description du poste

Nalys is seeking a CSV & Data Integrity Lead to join a remediation program at a leading Belgian pharmaceutical site in Brabant wallon. You will reassess data integrity gaps, validate gap closures, and build a defensible risk picture to guide remediation or replacement decisions.

Reporting to the program lead, you will collaborate with quality, engineering, and IT/OT teams, challenge past conclusions with rigor, and document technical justifications for management sign-off.