Quality Assurance Engineer

Pauwels Consulting; Geel; On-site; EUR 60,000 - 90,000; Full time

Job summary

Pauwels Consulting is seeking a Quality Manager to oversee third-party computerized systems in the global pharma arena. You will lead qualification assessments, risk-based oversight, and the development of quality agreements with external providers.

You will maintain the qualified third-party database, monitor performance, drive continuous improvement, and ensure complete documentation of all quality activities.

Qualifications

• 2+ years of experience in a GxP-regulated environment focusing on third-party quality management.
• Knowledge of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• 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

Quality management

Regulatory knowledge

Education

Bachelor or Master in Life Sciences / Engineering / Computer Sciences

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.

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.

Requirements

• 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).