供应商审核工程师

A career at Merck is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and electronics. For more than 352 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Your role:

Overall Objectives of the Position

• Conduct internal and external 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, Staff Managers 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;
• Is responsible for supplier/CMO Quality audits performed in time, audit reports are available as well as CAPA’s of the suppliers. Follow up of CAPA’s with suppliers and final audit closure.
• 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 complaints for better supporting of 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 manage Emprove Documentations as per company’s strategy
• Other assigned works from line manager.

Who you are:

Education and Qualification Required

• Education: Bachelor or above.
• Working Experience:

               1. Minimum 5 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 8/9/10, ISO 9000 series)

• Technical & Professional Knowledge:

           1. Well verse in spoken and written English language, as well as a native Chinese language capability.

           2. Skilful in using office application software (MS-Word, MS-Excel, MS-Outlook)

           3. Inter-cultural competence

          4. Willing and being able to travel frequently.

HR: 89829

Functional Area: Quality

What we offer: At Merck, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at come2merck.com