GMP Operation Compliance Scientist Full-time

Biopharmaceutical Contract Manufacturing

Boehringer Ingelheim aims to become China's first international provider of biopharmaceutical contract manufacturing solutions with all-round services to its clients in China and all over the world. As the leader in biopharma CMO manufacturing, Boehringer Ingelheim introduces innovative business models into China to further promote development of China's biopharma industry, boosting global competitiveness of Chinese biopharma companies, and facilitating clinical research and market launch of China's innovative medicines in a bid to accelerate growth of China's bio-technology industry. The Company's state-of-the-art production platform, management system and global biopharma network will help bio-medicines made by Chinese companies to enter the global markets.

Responsibilities

• Carry on investigation of deviation for Drug product Production, including investigation of GMP compliance-related deviation and document review of technical event/deviation when necessary;
• Regular follow-up deviation/CAPA closure status;
• 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 Manager 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.