Qa Operations Specialist (M/F/D)

Location: Baarle-Nassau, Netherlands
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.
Key Responsibilities:
• 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.

Essential Requirements:
• MBO/HBO level, preferably in a scientific field.
• Knowledge of quality system (GMP), and basic knowledge of regulatory requirements.
• English fluently, verbally and in writing
Desirable Requirements:
• Experience with radiation, PET or radiopharmaceuticals.
WHY CONSIDER NOVARTIS?
Almost 1 billion! That’s how many lives our product touch globally. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous, and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis, one of the largest pharma companies in the Netherlands!
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
For more information about the position, please contact the Staffing Center via [email protected]