OT Quality & Compliance Specialist (Pharma, Hybrid)

Novartis; Puurs-Sint-Amands; Hybrid; EUR 61,000 - 114,000; Full time

Job summary

Novartis Puurs site is seeking an OT Quality Associate to ensure an audit-ready OT environment. You will develop, maintain, and continuously improve procedures, SOPs, and handbooks, while supporting internal and external audits.

Ideal candidates hold an engineering degree with 5+ years in OT Quality/CSV, strong PLC/SCADA knowledge, and fluency in English and Dutch. The role includes hybrid work at Puurs, Belgium, with 3 days in office and exposure to QA, CSV, and regulatory processes.

Qualifications

• 5+ years in OT Quality / CSV, including 3+ years in pharma
• Experience with PLC, SCADA, automation and CSV
• Experience in user access reviews and audit reviews
• Project management and technical knowledge for compliant projects
• Advanced HSE and GxP / QA knowledge
• Fluent in English and Dutch

Responsibilities

• Ensure audit-ready OT environment through procedures, work instructions and handbooks
• Conduct quality reviews and support internal/external audits
• Manage user access reviews and audit trails (TATR)
• Follow up CAPAs and deviations; update and restructure SOPs and handbooks
• Manage server licenses, certificates and vendor onboarding
• Support supplier contracts, SLAs and MSCs; lead improvement projects

Skills

OT Quality

CSV

Audit readiness

PLC/SCADA

Quality improvement

Education

Engineering degree (Dipl. Ing./M.Sc./B.Sc.)

Tools

PLC

SCADA

Automation

OT CSV

Job description

Novartis Puurs site is seeking an OT Quality Associate to ensure an audit-ready OT environment. You will develop, maintain, and continuously improve procedures, SOPs, and handbooks, while supporting internal and external audits.

Ideal candidates hold an engineering degree with 5+ years in OT Quality/CSV, strong PLC/SCADA knowledge, and fluency in English and Dutch. The role includes hybrid work at Puurs, Belgium, with 3 days in office and exposure to QA, CSV, and regulatory processes.