OT Quality Specialist — Hybrid, Pharma Audit-Ready

Biopharma Careers; Puurs; Hybride; EUR 61 000 - 114 000; Plein temps

Avantages offerts par ce poste

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working

14 weeks parental leave

Résumé du poste

Novartis in Puurs, Belgium, seeks an OT Quality Associate to ensure an audit-ready OT environment. You will develop procedures, maintain handbooks, and support internal and external audits.

The role requires managing access, reviewing technical trails, and driving improvement projects for equipment and facilities. Ideal candidates bring 5+ years in OT Quality/CSV, pharma experience, and fluency in English and Dutch.

Qualifications

• Degree in engineering (Dipl. Ing. / M.Sc. / B.Sc.) or equivalent.
• 5+ years experience in OT Quality / CSV essential, including 3+ years in pharma.
• Experience with PLC, SCADA, automation, CSV, OT CSV.
• Experience in User Access reviews and management of user groups; Technical audit trail reviews (TATR); Incident reviews.
• Strong project management and technical knowledge, including automation.
• Advanced HSE and GxP / QA knowledge.
• Fluent in English and Dutch.

Responsabilités

• Ensure audit-ready OT environment by developing and maintaining procedures and handbooks.
• Conduct quality reviews and support internal and external audits.
• Perform User Access reviews and manage user groups.
• Lead or contribute to improvement projects for equipment, utilities and facilities.
• Manage vendors, contracts, SLAs, and MSCs.

Connaissances

OT Quality

CSV

Quality auditing

User Access reviews

Project management

English

Dutch

Formation

Dipl. Ing./M.Sc./B.Sc.

Outils

PLC

SCADA

Automation

OT CSV

Description du poste

Novartis in Puurs, Belgium, seeks an OT Quality Associate to ensure an audit-ready OT environment. You will develop procedures, maintain handbooks, and support internal and external audits.

The role requires managing access, reviewing technical trails, and driving improvement projects for equipment and facilities. Ideal candidates bring 5+ years in OT Quality/CSV, pharma experience, and fluency in English and Dutch.