Assistant QC Manager at BoehringerPRD

Shanghai, Shanghai, China -

Full Time

Start Date

Immediate

Expiry Date

06 Sep, 26

Salary

0.0

Posted On

08 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Microbiology Laboratory Management, GMP, SAP, Project Management, Microbial Analysis Method Transfer, Quality Control, Personnel Leadership, Environmental Monitoring, Equipment Qualification, SOP Development, Lean Methodology, Communication Skills, Negotiation, Time Management, Planning, Customer Service Focus

Industry

Pharmaceutical Manufacturing

Description

About Human Pharmaceutical BusinessWith 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: Responsible for managing the microbiology laboratory, including daily work scheduling, optimizing personnel utilization efficiency, completing various testing tasks on time, ensuring all testing processes are in a controlled state, and also supporting inspection-related tasks for other QC groups. Organize the team for carrying out daily sampling and testing for Water sample, environmental monitoring sample, compressed air sample, clean verification sample and finished products, ensure to complete testing and releasing timely. Organize personnel to conduct microbiological testing of raw and auxiliary materials, packaging materials, intermediate products, to be packaged, stability samples and finished products, ensure to complete testing and releasing timely. 4.Execute lab equipment qualification and maintenance, ensure to perform all tests smoothly. Release or reject related materials, to ensure the compliance with testing standard; And then release / reject materials in SAP system. As core member to lead the Microbial analysis method transfer and Verification to support the new product launch and transfer. Establish testing specifications, relevant SOPs/Forms, and other documents according to given instructions, ensure to comply with GMP, regulatory and BI requirements Responsible for promoting a culture of quality and lean projects within the Q department, ensuring continuous optimization and improvement of the lean system. Be a role model & lead the following the principles. Coach and develop QC employees. Requirements： Experience in similar role, minimum of 5 years' MNC experience of QC; minimum of 3 years' leadership experience Excellent knowledge of GMP Good specific knowledge relevant to the area/field Excellent English language skills, both verbal and written Good knowledge of project management Good organization and planning skills; good time management for emergent issue and priorities, and good at communication and team work spirit. Customer service focus and understanding of clients’ needs Confidence, professionalism, and efficiency in managing responsibilities Adaptability to change, willingness to share and learn Excellent communication, negotiation and persuasion skills

Responsibilities

Manage the microbiology laboratory, overseeing daily scheduling, sampling, and testing of materials and finished products. Lead microbial analysis method transfers and ensure compliance with GMP and regulatory requirements while coaching QC employees.