摘要
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.
About the Role
#LI-Onsite
Internal job title: QA operations Specialist
Location: Baarle Nassau, Netherlands
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
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.
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
Innovative Medicines
NL42 (FCRS = NL042) IDB Holland BV
Temporary (Fixed Term)
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.