Job Description Summary
We are seeking a QA Operations Specialist to help us with 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 role will work directly with the Quality and Operations Team, and reports to the QA Operational Manager.
Job Description
Major accountabilities:
- Prepare and perform QA review of batch release documents and supports the Quality Responsible with the batch release process, as well as guarantee the correct document lifecycle management (paper and electronic system).
- Release of starting materials and incoming goods.
- On-site Quality support for operational activities including interventions.
- Approve and review quality related documentation (operational procedures, protocols, and work instructions), and ensures archiving of batch documentation.
- Supports with deviation management. Ensures that the appropriate impact assessments are performed in a timely matter as well as the deviations are closed promptly.
- 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, change controls, preparation and execution of internal audits and Health Authorities inspections, and also support in improvement projects.
Minimum Requirements:
- MBO/HBO level, preferably in a scientific field.
- Knowledge of quality system (GMP), and basic knowledge of regulatory requirements.
- English fluent, verbally and in writing
- Willing to do shift work
Desirable Requirements:
- Experience with radiation, PET or radiopharmaceuticals.
Why Novartis
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we
Achieve This? With Our People. It Is Our Associates That Drive Us Each Day To Reach Our Ambitions. Be a Part Of This Mission And Join Us! Learn More Here
https://www.novartis.com/about/strategy/people-and-culture
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.
Join Our Novartis Network
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about
Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Skills Desired
Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management
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What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
