SUMMARY

Step into a role where your expertise in Quality Assurance directly supports the timely release of life-saving medicines. As a QA Operations Specialist, you’ll be at the heart of GMP operations, ensuring every batch meets the highest standards of compliance and quality. Your work will help safeguard patient trust and uphold Novartis’ commitment to excellence. If you thrive in a fast-paced, solution-oriented environment and want to make a real difference, this is your opportunity.

ESSENTIAL REQUIREMENTS:

• MBO/HBO level education, preferably in a scientific field
• Fluent in English, both spoken and written
• Familiarity with quality systems (GMP)
• Basic understanding of regulatory requirements
• Strong affinity for and awareness of quality-related topics
• Excellent organizational skills and attention to detail
• Demonstrates appropriate urgency and ownership of assigned tasks

DESIRABLE REQUIREMENTS:

• Experience with radiation, PET or radiopharmaceuticals.

KEY RESPONSIBILITIES:

• Review batch release documentation and support the Quality Responsible in the release process
• Provide on-site QA support for operational activities and interventions
• Ensure proper lifecycle management and archiving of batch documentation
• Release starting materials and incoming goods in compliance with quality standards
• Conduct visual monitoring during surprise inspections
• Approve and review operational procedures, protocols, and work instructions
• Manage deviations, ensuring timely impact assessments and closure
• Review and approve investigations for OOS, OOT, OOE, and system suitability failures
• Support timely execution of CAPAs and defined actions
• Assist in internal audits, inspections, and continuous improvement projects