OT Quality Associate

BE13 (FCRS = BE013) Novartis Manufacturing NV; Puurs; Hybride; EUR 61 000 - 114 000; Plein temps

Avantages offerts par ce poste

Hybrid work option

14 weeks parental leave

Insurance and retirement benefits

Résumé du poste

Novartis Puurs site seeks an OT Quality Associate to ensure an audit-ready OT environment by developing, maintaining and improving procedures, work instructions and handbooks, and by supporting audits.

The role requires a degree in engineering, 5+ years in OT Quality/CSV (3+ in pharma), strong PLC/SCADA and automation knowledge, and fluent English and Dutch; hybrid work 3 days in office.

Qualifications

• Degree in engineering or equivalent required.
• 5+ years OT Quality / CSV experience, with 3+ years in pharma.
• Strong PLC/SCADA and automation knowledge.
• Experience with user access reviews.
• GxP, QA and HSE knowledge.

Responsabilités

• Ensure audit-ready OT environment through procedures and handbooks.
• Support internal and external audits.
• Manage user access reviews and groups.
• Lead or contribute to CAPAs, deviations, and improvements.
• Manage vendor onboarding and supplier contracts and SLAs.

Connaissances

User Access reviews

PLC/SCADA

Automation

Quality Assurance

Audit readiness

Formation

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

Outils

PLC software

SCADA systems

Description du poste

Salary Range: €61,300.00 - €113,900.00 Band Level 4 Job Description Summary Location: Puurs, Belgium #LI-Hybrid 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
• Support internal and external audits, and lead or contribute to improvement projects for equipment, utilities and facilities
• 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
• Supplier & Contract Management: establish supplier contracts, SLAs and MSCs
• Supplier & Contract Management: 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
• 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.
• Eligible for a performance-based bonus depending on certain performance parameters.
• 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.
• Flexible and hybrid working options, where possible
• Minimum 14 weeks paid parental leave.

Skills Desired

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

• Business Continuity, Cost Management, Decision Making, Operational Excellence, Problem Solving, Project Management, Quality Compliance, Risk Management, Stakeholder Management, Vendor Management

In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov.