CSV QA Specialist – GxP Validation & Automation

Pauwels Consulting; Beerse; On-site; EUR 70,000 - 100,000; Full time

Job summary

Pauwels Consulting is seeking a highly qualified QA professional with a strong background in CSV, validation, and quality assurance within a GxP environment. The role emphasizes maintaining validated states, handling change control, and managing deviations to ensure compliance.

The successful candidate will bring hands-on experience with GMP guidelines (GAMP 5, EU GMP Annex 11, US FDA 21 CFR Part 11), along with familiarity with PLC and SCADA within manufacturing and automation settings.

Qualifications

• Bachelor or Master in engineering or related technical discipline.
• 4+ years in CSV/validation/QA in a GxP environment.
• Experience with change control, deviation management and maintenance of validated state.
• Knowledge of GAMP 5, EU GMP Annex 11 and US FDA 21 CFR Part 11.
• Experience with PLC and SCADA manufacturing/automation systems.
• Fluent in English.

Skills

CSV validation QA in GxP environments

Change control

Deviation management

Validated state maintenance

GAMP 5 knowledge

EU GMP Annex 11

US FDA 21 CFR Part 11

PLC systems

SCADA systems

English fluency

Education

Bachelor or Master in Engineering/Technical discipline

Tools

Active Directory

SIMATIC Logon

Industrial networks

Job description

Pauwels Consulting is seeking a highly qualified QA professional with a strong background in CSV, validation, and quality assurance within a GxP environment. The role emphasizes maintaining validated states, handling change control, and managing deviations to ensure compliance.

The successful candidate will bring hands-on experience with GMP guidelines (GAMP 5, EU GMP Annex 11, US FDA 21 CFR Part 11), along with familiarity with PLC and SCADA within manufacturing and automation settings.