GMP Operation Compliance Scientist
Boehringer Ingelheim View all jobs
- Shanghai
- Permanent
- Full-time
- Carry on investigation of deviation for Drug product Production, including investigation of GMP compliance-related deviation and document review of technical event/deviation when necessaryï¼›-Regular follow-up deviation/CAPA closure statusï¼›-Responsible for regular internal GMP Walk down in DP production ,including report improvement opportunities, track the execution of action plans, and trending analysis;-Work as a training coordinator at the department level, maintain and update training matrix, training plan for all staffs in the DP production;-Support orientation training for all new employee of DP production and department GMP yearly training;-Responsible for GMP document system at the department level, develop and maintain GMP documentation/archiving to ensure GMP compliance as defined procedures/regulations. Create and maintain accurate and updated GMP production documents e.g. MBR and SOPs.-Work as a Doc coordinator for DP production, create and maintain production-relevant documents in IDEA for DP production;-Proactively monitor the ongoing manufacturing processes, propose/execute necessary operation optimization/improvements from the GMP perspective.-Support GMP Compliance Manger to continuously improve GMP compliance within the Operations team.Qualifications
-Bachelor's degree or above-+3 years of quality/GMP compliance working experience in pharmaceutical company-Fluent Chinese and English;-Good in technical writing skills and communication skills.