GMP CSV QA Specialist - Validation & Quality

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

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

CSV QA

IT Quality

Validation QA

GMP knowledge

GAMP 5

Data Integrity

Documentation

Communication skills

Independent worker

Dutch & English

Formazione

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

Descrizione del lavoro

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.