Quality Assurance Operations Specialist

Please note: This is a 100% on-site position and is not eligible for remote or hybrid work. Candidates must be available to work within a 24/7 shift schedule.

Major Accountabilities:

• Prepare and perform QA review of batch release documents and supports the Quality Responsible with the batch release process.
• On-site Quality support for operational activities including interventions.
• Guarantee the correct document lifecycle management (paper and electronic system). Ensures archiving of batch documentation.
• Release of starting materials and incoming goods.
• Perform Visual Monitoring on Surprise on-site inspections.
• Approve and review quality related documentation (operational procedures, protocols, and work instructions).
• Supports with deviation management. Ensures that the appropriate impact assessments are performed in a timely matter. Ensures that deviations are closed in a timely matter.
• Review and approve the investigations in case of analytical results out of specification (OOS), out of trend (OOT), out of expectation (OOE) or System Suitability Test failures.
• Supports with CAPA’s and Actions and timely execution of defined actions.
• Supports with change controls and timely execution of defined actions.
• Support the preparation and execution of internal audits and Health Authorities inspections

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Obligatory requirements: ​

• Education: MBO/HBO level, preferably in a scientific field.
• Experiences: Solid knowledge of quality system (GMP) and basic knowledge of regulatory requirements.
• Strong affinity with and awareness of quality issues.
• Good organizational skills including attention to details.
• Shows the appropriate sense of urgency around given tasks, work in team.
• Languages: English fluently, verbally and in writing.
• Work in shifts

Desirable requirements:

• Optional: Experience with radiation, PET or radiopharmaceuticals is highly valued.

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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? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.