QC Analyst

About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, the company will launch new medicines or indications in therapeutic areas including CV & metabolism, respiratory, oncology, immunology, CNS and retinal health to meet the demand of Chinese patients.

Job Responsibilities:
1、Carry out sampling and testing of raw materials, intermediate products, products to be packaged, finished products and stability, to ensure that the sample analysis tasks are completed on time.
2、Complete the transfer, confirmation and verification of analytical methods for relevant products as required.
3、Establish and regularly review quality standards TS, SOPs, forms and other related documents according to instructions to ensure compliance with GMP specifications and BI requirements.
4、Carry out verification and maintenance of laboratory equipment as required to ensure smooth execution of all testing tasks.
5、Perform relevant testing and evaluation involving supplier qualifications, testing and investigation of complaint samples and defective materials in production, and handle laboratory abnormal events and non-standard investigations. Actively participate in rectification of defects discovered during self-inspection.
6、Keep the laboratory tidy and clean at all times. Maintain and optimize the testing process including the management of equipment, glassware and reagents to ensure efficient and economical compliance with SFDA and company guidelines.
7、Actively participate in a series of training activities organized internally. Develop various job skills and pursue continuous improvement.
8、Strictly implement the relevant standard operating procedures and rules and regulations of the laboratory. Fill in relevant documents and records such as inspection records, logbooks and other records in a timely manner as required to ensure that BI's GDP requirements are met.

Requirements：
•Good knowledge of GMP, and more than one year QC analysis related experience
•Familiar with related local regulations
•Bachelor or above , Pharmacy of relevant, Good English skills
•Experience in similar role, prefer with Pharma operation/multinational background or experience
•Good at communication and team work spirit.
•Adaptability to change, willingness to share and learn
•Good analytical and scientific thinking and problem solving skills