Quality Operations Coordinator
About the Role
Major accountabilities:
- Ensure production processes are performed in compliance with GMP rules
- Control batch records and release batches timely in order not to interrupt shipment program
- Perform investigation, evaluation and reporting of complaints and deviations
- Control and complete distribution of documents according to procedures
- Ensure that the risk assessment related to Quality Assurance are done.
- Follow up with the Quality system/GMP audit results of the Health Authorities and Novartis Companies
- Contribute to the cost effectiveness and development projects concerning the Quality Assurance Department.
- Ensure that all issue related to the local and Novartis HSE&BC regulations are handled accordingly.
Key performance indicators:
- On-time and GMP-compliant release of dosage forms -No Complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand.
- Successfully Support continuous improvement Projects -Executes batch release in compliance with registration.
Minimum Requirements:
- University degree in Pharmaceuticals, Chemical Engineering or Chemistry
- Minimum 5 years of experience in a similar position at a multinational pharmaceutical company
- Extensive knowledge of GMP
- Preferably SAP knowledge
- Excellent communication skills in English
- Team working and customer-oriented mindset
- Ability to work in a fast-paced changing environment
- Detail-oriented, willing to work in a challenging environment
Skills:
- Continuous Learning.
- Managing Complexity.
- Employee Performance Evaluations.
- GMP Procedures.
- QA (Quality Assurance).
- Technological Expertise & Intelligence.
Languages :
- English.
Role Requirements
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
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