QA Operations Specialist – 24/7 On‑Site GMP Batch Release

NL42 (FCRS = NL042) IDB Holland BV; Baarle-Nassau; On-site; EUR 34,000 - 82,000; Full time

Job summary

Novartis in Baarle Nassau, Netherlands is seeking a detail-oriented QA Operations Specialist to support a 24/7 shift-based GMP environment. This on-site role focuses on on-time batch release and QA activities to ensure regulatory compliance and proper documentation.

You will perform batch release reviews, provide site QA support, manage document lifecycles, and assist with deviations, CAPAs, and internal audits. Rolling shifts including days, evenings, nights, weekends, and holidays are required.

Qualifications

• Education: MBO/HBO level, preferably in a scientific field.
• Solid knowledge of GMP and basic regulatory requirements.
• Strong organizational skills with attention to detail.
• Fluent in English, both written and spoken.

Responsibilities

• Prepare and perform QA review of batch release documents and support the batch release process.
• On-site QA support for operational activities including interventions.
• Ensure proper document lifecycle management (paper and electronic systems) and archiving.
• Support deviation management and investigations related to OOS/OOT/OOE and CAPA actions.

Skills

Collaboration

Communication

Data Integrity

Dealing With Ambiguity

Digital Savviness

Leadership

Operational Excellence

Problem Solving

Regulatory Knowledge

Education

MBO/HBO level in scientific field

Job description

Novartis in Baarle Nassau, Netherlands is seeking a detail-oriented QA Operations Specialist to support a 24/7 shift-based GMP environment. This on-site role focuses on on-time batch release and QA activities to ensure regulatory compliance and proper documentation.

You will perform batch release reviews, provide site QA support, manage document lifecycles, and assist with deviations, CAPAs, and internal audits. Rolling shifts including days, evenings, nights, weekends, and holidays are required.