OT Quality Associate

Novartis; Puurs-Sint-Amands; Hybride; EUR 61 000 - 114 000; Plein temps

Avantages offerts par ce poste

Hybrid working options

Parental leave (14 weeks)

Résumé du poste

Novartis in Puurs, Belgium, is seeking an OT Quality Associate to ensure an audit-ready OT environment. The role involves developing and maintaining procedures, carrying out quality reviews, and supporting audits at a site with hybrid work arrangements.

The ideal candidate has 5+ years in OT Quality/CSV, 3+ years in pharma, and strong PLC/SCADA automation knowledge, plus fluency in English and Dutch. The position offers a hybrid schedule and a competitive compensation package.

Qualifications

• 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.

Responsabilités

• 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.

Formation

Degree in engineering (Dipl. Ing. / M.Sc. / B.Sc.) or equivalent

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.

Job Description

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.

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 to113,900.00 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.

Skills Desired

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