Summary
About the Role
Major accountabilities:
- Ensure production processes are performed in compliance with GMP rules
- Handle the complaints timely by gathering the necessary information from related departments and document in AQWA/CRTS database
- Handle deviations timely by contributing the investigations, giving QA decision and follow-up the necessary actions to be taken
- Perform quarterly and annually reporting of customer complaints and deviations
- Control batch records timely in order not to interrupt shipment program
- Ensure that the Risk Assessments related to the Quality Assurance are done
- Ensure that all issue related to the local and Novartis HSSE&BC regulations are handled accordingly.
- Perform investigation, evaluation and reporting of complaints
- Barch record , BOM, EBR review.
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 2 years of experience in a similar position at a multinational pharmaceutical company
- Knowledge of GMP is must
- 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
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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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
