Quality Assurance Engineer

Pauwels Consulting; Geel; On-site; EUR 60,000 - 85,000; Full time

Job summary

Pauwels Consulting is seeking a Quality Management professional to oversee the quality of third-party computerized systems providers for a global pharmaceutical client in Belgium. You will perform qualifications, risk-based evaluations, maintain quality agreements, manage the qualified third-party database, monitor performance, and ensure documentation of all activities.

Candidates hold a life sciences/engineering/computer sciences degree with 2+ years in a GxP-regulated environment and

Qualifications

• Bachelor or Master in Life Sciences, Engineering, Computer Sciences, or a related field.
• 2+ years of experience in a GxP-regulated environment with a focus on third-party quality management.
• Knowledge of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Strong analytical and risk assessment skills.
• Fluent in Dutch and English.

Responsibilities

• Perform qualification assessments of third-party computerized systems providers to verify suitability and competence.
• Conduct risk-based evaluations of external partners to determine appropriate quality control and oversight levels.
• Develop and maintain quality agreements and contractual quality clauses with third-party suppliers.
• Manage and update the qualified third-party database to ensure accurate referential data.
• Monitor routine quality performance of qualified partners and lead continuous improvement initiatives.
• Ensure comprehensive documentation and record-keeping of all third-party quality activities.

Skills

Analytical skills

Risk assessment

Dutch (fluent)

English (fluent)

Education

Bachelor or Master in Life Sciences, Engineering, Computer Sciences, or related field

Tools

CSV

Job description

Our client, a global pharmaceutical organization, is seeking a professional to oversee the quality management of third-party computerized systems providers. The role ensures that all external partners meet rigorous regulatory standards and internal compliance requirements through assessments and continuous performance monitoring.

• Perform qualification assessments of third-party computerized systems providers to verify suitability and competence.
• Conduct risk-based evaluations of external partners to determine appropriate quality control and oversight levels.
• Develop and maintain quality agreements and contractual quality clauses with third-party suppliers.
• Manage and update the qualified third-party database to ensure accurate referential data.
• Monitor routine quality performance of qualified partners and lead continuous improvement initiatives.
• Ensure comprehensive documentation and record-keeping of all third-party quality activities.

• Bachelor or Master in Life Sciences, Engineering, Computer Sciences, or a related field.
• You have 2+ years of experience in a GxP-regulated environment with a focus on third-party quality management.
• You bring knowledge of relevant regulations and guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• You possess strong analytical and risk assessment skills.
• You are fluent in Dutch and English.

Nice to Haves

• Knowledge of Computerized Systems Validation (CSV).