Quality Assurance Operations Specialist

Job Description Summary

The Quality Assurance Operations Specialist provides QA support for all shopfloor GMP related activities. The main focus is linked to the on-time batch release process and all related operational activities to ensure that the batches are released according to regulatory compliance and the local quality system. This ranges from material release and batch record reviews, to deviation support and technical QA support (e.g. calibrations, interventions).

 

Job Description

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.

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.

 

Skills Desired

Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge