OT Quality Associate

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

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;
• 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

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.