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Novartis

Global pharmaceutical company delivering science-based innovations

OT Quality Associate

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timePuurs-Sint-Amands, Belgium

About the Job

Requirements

  • A degree in engineering (Dipl. Ing., M.Sc., or B.Sc.) or equivalent is required.
  • At least 5 years of experience in OT Quality / CSV, including at least 3 years of experience in pharmaceuticals.
  • Good experience and understanding in PLC, SCADA, automation, CSV, and OT CSV.
  • Experience in user access reviews and management of user groups, technical audit trail reviews (TATR), and incident reviews.
  • Project management and technical knowledge, including automation, with the proven ability to deliver safe, effective, and fully compliant projects.
  • Advanced HSE and GxP / QA knowledge.
  • Fluency in English and Dutch is required.

Responsibilities

  • Conduct user access reviews and manage user groups; perform technical audit trail reviews (TATR) and incident reviews.
  • Support and follow up on CAPAs and deviations; verify, update, and restructure OT procedures and SOPs, including creating a clear graphical overview and interlinking.
  • Manage Automation Operational Handbooks and create AOHs for the most important OT systems.
  • Manage exceptions, including patching and shared privileged accounts.
  • Manage server licenses and certificates.
  • Manage vendor onboarding (VSQAPS) and vendor support.
  • Support internal and external audits.
  • Support internal and external audits, and lead or contribute to improvement projects for equipment, utilities, and facilities.
  • Select suppliers and contractors in line with the appropriate strategy; establish supplier contracts, SLAs, and MSCs; manage project suppliers, contractors, and third parties.

Desired Qualifications

  • Business continuity.
  • Cost management.
  • Project management.
  • Quality compliance.
  • Risk management.
  • Stakeholder management.
  • Vendor management.

About the Company

Novartis

Global pharmaceutical company delivering science-based innovations

Novartis is a global pharmaceutical company that uses science-based innovations to develop treatments and improve patient outcomes worldwide. Its products are medicines developed through research and development to address various diseases, aiming to reach nearly 1 billion people. The company differentiates itself by large-scale investment in R&D, a global presence with a diverse workforce, and a clear mission to Reimagine Medicine, focusing on meeting the changing needs of patients. Its goal is to improve quality of life and extend life expectancy by delivering meaningful therapies through its research and development efforts.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1970

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