QA Engineer Thrid Party

Akkodis; Antwerpen; On-site; EUR 60,000 - 90,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

GxP experience

Third-party QA

CSV knowledge

Regulatory compliance

Risk assessment

Dutch & English

Education

Life Sciences / Engineering / CS degree

Job description

Akkodis is a global digital engineering and smart industry leader, bringing together talent and technology to engineer a smarter future. With more than 50,000 experts worldwide and over 1,000 in Belgium, we support companies across industries in innovation, digital transformation and R&D; from consulting and talent solutions to end-to-end project delivery. Driven by passion, expertise and impact, we make incredible happen.

In Belgium, we operate through 7 dedicated practices, where our consultants receive the technical guidance, coaching and support they need to grow and fully unlock their potential. We believe in empowering our talent by providing the right expertise, knowledge-sharing and development opportunities to help them thrive. Our practices: Product & System Development, Validation & Verification, Manufacturing & Operations, Cloud Infrastructures & Security, Data Analytics & Artificial Intelligence, Digital & Software and Wireless & Connectivity.

Akkodis is part of the Adecco Group. You can find more information on our website : www.akkodis.com

You will support the qualification and ongoing quality oversight of third-party computerized systems providers. In this role, you will assess provider legality, suitability, and competence in line with client requirements and local regulations, while also supporting risk-based evaluations, quality agreements, and documentation controls. The position requires close attention to computerized systems quality management, third-party oversight, and regulatory expectations in a GxP-regulated environment.

Your responsibilities

• Perform qualification assessments of third-party computerized systems providers, on-site or remotely, in line with Sanofi 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 and contractual quality clauses 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.
• Ensure accurate documentation and record-keeping for all third-party quality activities.

What skills do you bring to the table?

• At least 2 years of experience in a GxP-regulated environment with a focus on third-party quality management.
• Knowledge of computerized systems validation (CSV) is an asset for this position.
• Familiarity with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 is required.
• Strong analytical skills and the ability to perform structured risk assessments.
• Fluency in Dutch and English, both written and spoken, is required.
• Bachelor’s or Master’s degree in Life Sciences, Engineering, Computer Sciences, or a related field is preferred.

Our recruitment process

Stage 1: Initial telephone interview (15 min) with @Bo, Talent Acquisition Specialist.

Step 2: Interview (60 min) with a Business Manager.

Step 3: Interview (60 min) with the client.