Quality Assurance Operations Specialist

About the role

Novartis is looking for a detail‑oriented Quality Assurance Operations Specialist to support its 24/7 shift‑based manufacturing operation in Baarle‑Nassau, Netherlands. The role ensures timely batch release and compliance with GMP and regulatory requirements.

Key responsibilities

• Prepare and perform QA review of batch release documentation and support the Quality Responsible in the release process.
• Provide on‑site QA support for shop‑floor GMP activities, including interventions, calibrations and other operational tasks.
• Manage documentation lifecycle, ensuring review, approval, archiving and control of both paper‑based and electronic records.
• Review and release starting materials and incoming goods in line with procedures and GMP standards.
• Support investigations of deviations, OOS, OOT, OOE and system suitability test failures, including impact assessment and timely closure.
• Assist with CAPA, change control, internal audits and health‑authority inspection readiness.

Required profile

• Education at MBO or HBO level in a scientific, pharmaceutical, life‑sciences or related field.
• Solid knowledge of GMP quality systems and basic understanding of regulatory requirements.
• Strong organizational skills, attention to detail and ability to prioritize in a dynamic environment.
• Fluent written and spoken English and willingness to work rotating shifts, including nights and weekends.

Required skills

• GMP compliance
• Batch release documentation review
• Calibration and intervention support
• Deviation and investigation handling
• CAPA and change control processes

What we offer

• Competitive base salary ranging from €44,100 to €81,900 per year.
• Performance‑based bonus potential.
• Comprehensive benefits including insurance, retirement plans, wellbeing resources and parental leave.
• Flexible and hybrid working options where possible.
• Commitment to pay equity, diversity and inclusion.