Third-Party QA Engineer — CSV & GxP Compliance

Akkodis; Antwerpen; In loco; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

Akkodis is seeking a Quality Assurance Specialist in Antwerp to lead qualification assessments of third-party computerized systems providers in a GxP environment. You will conduct risk-based evaluations, review external audits, and help maintain quality agreements with suppliers in line with client requirements and regulatory expectations.

Required are at least 2 years in a GxP-regulated setting, knowledge of CSV, familiarity with FDA 21 CFR Part 11, EU Annex 11 and GAMP 5, plus fluency in Dutch

Competenze

• Minimum 2 years' experience in a GxP-regulated environment focused on third-party quality management.
• Knowledge of computerized systems validation (CSV) is an asset.
• Familiar with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Strong analytical skills and the ability to perform structured risk assessments.
• Fluency in Dutch and English.

Mansioni

• Perform qualification assessments of third-party CS providers, on-site or remotely, in line with client requirements and local regulations.
• Conduct risk-based evaluations of CS third parties to determine the appropriate level of quality control and oversight.
• Review related external audits as part of the evaluation of third-party quality and compliance performance.
• Develop, negotiate, and maintain quality agreements with third-party suppliers.
• Maintain and update the qualified CS Third Party list in the referential database at least twice yearly.
• Monitor routine quality performance of qualified third parties and support continuous improvement initiatives.

Conoscenze

GxP experience

Third-party QA

CSV knowledge

Regulatory compliance

Risk assessment

Dutch & English

Formazione

Life Sciences / Engineering / CS degree

Descrizione del lavoro

Akkodis is seeking a Quality Assurance Specialist in Antwerp to lead qualification assessments of third-party computerized systems providers in a GxP environment. You will conduct risk-based evaluations, review external audits, and help maintain quality agreements with suppliers in line with client requirements and regulatory expectations.

Required are at least 2 years in a GxP-regulated setting, knowledge of CSV, familiarity with FDA 21 CFR Part 11, EU Annex 11 and GAMP 5, plus fluency in Dutch