QC Specialist

About 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
- Perform routine and project-related QC testing for biopharmaceutical products in the Protein Analytics laboratory, including but not limited to electrophoresis, chromatography and other analytical methods.
- Execute analytical procedures in compliance with GMP, internal SOPs and applicable regulatory requirements, ensuring data accuracy, integrity and timely documentation.
- Prepare, review and maintain laboratory records, test reports, protocols, raw data and related quality documents in accordance with company standards.
- Support method validation, verification, transfer and lifecycle activities, including execution of experiments, data evaluation and preparation of required documentation.
- Participate in sample testing for release, stability, IPC, PPQ and other project needs to ensure timely delivery of QC commitments.
- Support deviation, OOS/OOE/OOT, CAPA and change control activities by providing technical input, investigation support and follow-up actions as required.
- Maintain laboratory instruments, reagents, reference standards and consumables to ensure inspection readiness and continuous laboratory operation.
- Contribute to audit and inspection preparation, regulatory submission support and continuous improvement initiatives within the QC Protein Analytics area.

Qualifications
-Bachelor or above in pharmacy，biochemistry，chemical analytics or related field

-Good knowledge of GMP. Familiar with Ch.P,

-Sense of urgency, precision and reliability

-Willing to learn and open to new ideas, constructive thinking, initiative and proactive

-Be able to work under pressure