QC Specialist社

面议

市辖区本科及以上1年及以上

发布时间：2023-09-06

职位描述

Talent@Boehringer Ingelheim


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 ******s 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.


Job Responsibilities
-The direction of this position is QC sample management and LIMS system maintenance
-Follow regulations and BI sops for sample management, including sample reception, sample distribution, sample aliquotation and destruction, etc., and record in time to ensure sample traceability
-Cooperate with Labs, Project team and Production team to formulate sampling plans, authorize and train production team to take samples, and ensure that no samples are missed in each batch of production
-Follow regulations and BI sops to manage reference standards and reserve samples
-Responsible for the collection of QC test records and reports, to ensure the completeness of the reports and records, and archive them in a timely manner
-Support LIMS master data maintenance and LIMS project implementation
-Responsible for the drafting or updating of samples and LIMS related processes
-Work hand-in-hand with regulatory affairs team for IND and NDA filings
-Support and participate in the audit
-Complete the tasks temporarily assigned by the QC manager
-Participate organization activities and contribute to the team
Qualifications
-Education/Degree Requirements: College degree with work experience or above
-Major: Biopharmaceutical, Biochemistry, Biology, Biotechnology and Pharmacy
-Language skills & proficiency: Good English writing, reading, listening and speaking
-Required capabilities (skills, experience, competencies):
-Good knowledge of GMP;
-Familiar with relevant local regulations and requirements;
-Good team player;
-Good organizing and communication ability;
-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;
-Can create new idea or innovative method to multiple functions;
-Good coaching ability;
-Good time management skill.
-At least 1 years’ experience in Quality Control in the biopharmaceutical or pharmaceutical industry company. Multinational pharmaceutical company experience is prefer*************************

其他要求

招聘人数：1人
职能类别：

公司介绍

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