供应商质量工程师

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

Your role:
Overall Objectives of the Position：
•    Conduct audits of manufacturers, laboratories, supplier, etc. to assure compliance to cGMPs/ISO.
•    Provides assistance in maintaining training program.
•    Resolve quality concerns and implement quality improvements by meeting with other department Managers, Supervisor to assure current methods, procedures or SOP’s meet current standards.
Main Tasks：
•    To work with global Supplier Quality Management team to ensure compliance with global strategy.
•    To manage all quality audit aspects of Suppliers, Contract Manufacturing Organizations (CMO’s), Repackagers, Distributors, Warehouses, Contract Laboratories as appropriate.
•    Responsible for supplier /CMO quality audit, timely provide audit report and supplier CAPA, and follow up supplier CAPA until the final audit.
•    To implement and execute activities associated with and relevant to the supplier quality audit tasks and other tasks that may support and enhance the safety and integrity of sourcing from China.
•    Perform risk management and routine surveillance of suppliers.
•    To manage raw material and packaging material complaints to better support production.
•    To conduct internal GMP/ISO audits of the manufacturing facilities to ensure GMP/ISO compliance.
•    To support customer audit and follow up of CAPA’s with internal department and make sure the audit closed in time.
•    To support quality system related works including deviation, change control, CAPA, risk management and so on.
•    Provides assistance in maintaining training program.
•    Strictly comply with company EHS safety regulations and master skill of safety work and emergency rescue knowledge.
•    To support Emprove Documentations as per company strategy.
•    Other assigned works from line manager.
•    Actively participate in quality culture building and quality related activities.
•    Actively report quality related events and participate in continuous quality improvement activities.

Who you are：
•    Education: Bachelor or above.
•    Working Experience: 
1.    Minimum 10 years of working experience in a pharmaceutical or biological GMP/ISO environment with some auditing experience.
2.    Expert knowledge of domestic and international regulations regarding Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) for Active Pharmaceutical Ingredients (APIs) and pharmaceutical/biological products.
3.  In-depth knowledge of Quality Systems and related norms (e.g. ICH Q7/8/9/10, ISO 9000 series)
•    Technical & Professional Knowledge: 
1.    Fluent in English. Good reading, writing and communication skills.
2.    Skilful in using office application software (MS-Word, MS-Excel, MS-Outlook)
3.    Inter-cultural competence
4.  Willing and being able to travel at least 30% of the time.

HR: 95989
Functional Area: Quality

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!