OT Quality Specialist – Pharma Compliance & Audits

Novartis Belux; Puurs; Hybride; EUR 61 000 - 114 000; Plein temps

Avantages offerts par ce poste

Hybrid work schedule

Parental leave 14 weeks

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Résumé du poste

Novartis Belux in Puurs, Belgium is seeking an OT Quality Associate to ensure an audit-ready OT environment. You will develop, maintain, and improve procedures, work instructions, and handbooks, and support internal and external audits.

Based at the Puurs site with 3 days in the office, the role focuses on access controls, audits, CAPAs, deviations, and vendor coordination to keep systems compliant. English and Dutch fluency required.

Qualifications

• 5+ years OT Quality/CSV experience, 3+ years pharma.
• Experience with PLC/SCADA and automation.
• Fluent in English and Dutch.
• Strong project management and QA knowledge.
• Experience with audits (internal/external).

Responsabilités

• Perform user access reviews and manage user groups; review TATR and incidents.
• Support CAPAs and deviations; update OT procedures and handbooks.
• Manage exceptions, patching, and shared privileged accounts.
• Oversee server licenses and certificates.
• Manage vendor onboarding, contracts, SLAs, MSCs.
• Support internal and external audits.
• Lead improvement projects for equipment, utilities, facilities.

Connaissances

OT Quality

CSV

PLC/SCADA

Audits & QA

Project management

HSE & GxP

English & Dutch

Formation

Engineering degree

Description du poste

Novartis Belux in Puurs, Belgium is seeking an OT Quality Associate to ensure an audit-ready OT environment. You will develop, maintain, and improve procedures, work instructions, and handbooks, and support internal and external audits.

Based at the Puurs site with 3 days in the office, the role focuses on access controls, audits, CAPAs, deviations, and vendor coordination to keep systems compliant. English and Dutch fluency required.