- To monitor and maintain work environment based on local regulatory requirement and NVS HSE policy appropriately.
2. Quality Control:
- To achieve product quality control through testing and inspection of raw materials,
drug products and finished products.
- To monitor product quality through FUST and commitment stability tests.
- To support process monitoring for process validation, implement and support
launch of new products, and support partial change applications.
- To provide associates with NOSSCE integrated business process and support the corresponding NOSSCE process owners to maintain Class A operation in its responsible areas.
Make and lead strategies and ensure execution of the followings:
- HSE improvement based on local regulatory requirement and NVS HSE policy
- Test planning
- Sampling and 100% ID check test
- Raw material testing and packaging material testing
- Drug product and final product testing (release test)
- FUST and stability testing
- Microbiological testing
- Environment monitoring
- Validation support (process validation, cleaning validation, e.t.c.)
- Method transfer
- Commitment stability
- Production transfer
- Regulatory support (JP Network)
- Compliant and deviation analysis
- API Variant change review
- Equipment management
- Apparatus management
- Reference standard management
- Retain sample management
- Laboratory IT project
Diversity & Inclusion / EEO
- Leadership exertion and organization management skill.
- Knowledge of the Pharmaceuticals and Medical Devices Law, GMP/ GCTP/ GQP and other related regulations, HSE local regulatory requirement and NVS HSE policy.
- Understanding of Novartis Quality System (QM / QD) and executing ability.
- Master degree of pharmaceutical science, chemical science, biological science, and engineering. Or equivalent.
- Communication and negotiation skill in the both of Japanese and English.