QA CSV

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

Job summary

Akkodis Belgium is seeking a QA CSV Specialist to support the quality and compliance of computerized systems within a GMP-regulated pharmaceutical environment. The role combines CSV expertise with broader QA responsibilities, ensuring systems and documentation meet regulatory requirements.

You will collaborate with Engineering, Validation, IT, Automation and other Quality teams across the system lifecycle from implementation to ongoing maintenance and continuous improvement.

Qualifications

• Bachelor's or Master's in Engineering, IT, Life Sciences or a related field.
• Experience in Computerized System Validation and QA within a regulated environment.
• Good knowledge of GMP and validation principles.
• Familiarity with GAMP 5, Data Integrity and the system lifecycle.
• Experience with Deviations, CAPAs, Change Controls and Risk Assessments.
• Experience in pharma/biotech or other highly regulated industries is a strong asset.
• Strong documentation and technical writing skills.
• Excellent communication and ability to work with cross-functional stakeholders.
• Ability to work independently and manage priorities.

Responsibilities

• Review and approve CSV documentation, including validation plans, risk assessments, qualification and validation protocols, test documentation and reports.
• Ensure computerized systems are validated and maintained in accordance with GMP requirements and GAMP principles.
• Provide QA oversight during the implementation, modification, qualification and validation of computerized systems.
• Review and approve GMP quality documentation such as Deviations, CAPAs, Change Controls and Risk Assessments.
• Support Data Integrity activities and ensure that computerized systems and processes meet applicable data integrity expectations.
• Participate in periodic reviews and other lifecycle activities related to validated computerized systems.
• Support audits and inspections by providing expertise and documentation related to CSV and IT quality.
• Perform or contribute to gap assessments and identify opportunities for improvement within computerized systems and quality processes.

Skills

CSV QA

IT Quality

Validation QA

GMP knowledge

GAMP 5

Data Integrity

Documentation

Communication skills

Independent worker

Dutch & English

Education

Bachelor's or Master's in Engineering/IT/Life Sciences

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

The QA CSV Specialist supports the quality and compliance of computerized systems within a GMP-regulated pharmaceutical environment. The role combines CSV expertise with broader QA responsibilities and ensures that computerized systems, related processes and documentation comply with applicable regulatory requirements and quality standards.

The QA CSV Specialist works closely with Engineering, Validation, IT, Automation, Operations and other Quality teams throughout the system lifecycle, from implementation and qualification to ongoing maintenance and continuous improvement.

Your responsibilities

• Review and approve CSV documentation, including validation plans, risk assessments, qualification and validation protocols, test documentation and reports.
• Ensure computerized systems are validated and maintained in accordance with applicable GMP requirements and GAMP principles.
• Provide QA oversight during the implementation, modification, qualification and validation of computerized systems.
• Review and approve GMP quality documentation such as Deviations, CAPAs, Change Controls and Risk Assessments.
• Support Data Integrity activities and ensure that computerized systems and processes meet applicable data integrity expectations.
• Participate in periodic reviews and other lifecycle activities related to validated computerized systems.
• Support audits and inspections by providing expertise and documentation related to CSV and IT quality.
• Perform or contribute to gap assessments and identify opportunities for improvement within computerized systems and quality processes.

What skills do you bring to the table?

• Bachelor's or Master's degree in Engineering, IT, Life Sciences, Pharmaceutical Sciences or another relevant scientific or technical discipline.
• Experience in Computerized System Validation, CSV QA, IT Quality, Validation QA or a related quality function within a regulated environment.
• Good knowledge of GMP and validation principles.
• Knowledge of GAMP 5, Data Integrity and computerized system lifecycle principles.
• Experience with quality systems such as Deviations, CAPAs, Change Controls and Risk Assessments.
• Experience within the pharmaceutical, biotechnology or another highly regulated industry is a strong asset.
• Strong documentation and technical writing skills.
• Analytical and quality-focused mindset with the ability to identify risks and improvement opportunities.
• Strong communication skills and the ability to collaborate with technical and quality stakeholders.
• Able to work independently, take ownership and manage priorities effectively.
• Professional proficiency in Dutch and English is mandatory

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.