OT Quality Associate

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

Summary

Location: Puurs, Belgium 3 days/week in office

Internal job title: OT Quality Associate

This role is based in Belgium. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

About The Role

The OT Quality Associate will join our site in Puurs and will be responsible for ensuring an audit-ready OT environment through the development, maintenance, and continuous improvement of procedures, work instructions, and operational handbooks, as well as conducting quality reviews and supporting internal and external audits.

Key Responsibilities

• Responsible for User Access reviews and management of user groups; Technical audit trail reviews (TATR); Incident reviews.
• Support and follow-up of CAPAs and deviations, verify and update OT procedures, restructure these SOPs, including creation of a clear graphical overview and interlinking; manage Automation Operational Handbooks, Create AOHs for our 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.
• Strategy & Organizational development: Support internal and external audits, and lead or contribute to improvement projects for equipment, utilities and facilities
• Supplier & Contract Management: Select suppliers and contractors while taking the appropriate strategy into account; establish supplier contracts, SLAs and MSCs; manage project suppliers, contractors and third parties.

Essential Requirements

• Degree in engineering (Dipl. Ing. / M.Sc. / B.Sc.) or equivalent.
• 5+ years experience in OT Quality / CSV essential, including 3+ years of experience in pharma.
• Good experience and understanding in PLC, SCADA, automation, CSV, OT CSV
• Experience in User Access reviews and management of user groups; Technical audit trail reviews (TATR); Incident reviews.
• Project management and technical knowledge, including automation, with proven ability to deliver safe, effective and fully compliant projects.
• Advanced HSE and GxP / QA knowledge.
• Fluent in English and Dutch.

Commitment To Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Why Novartis

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Accessibility And Accommodation

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Benefits & Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: 61,300.00 EUR to 113,900.00 EUR

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards

Learn about all the ways we’ll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)