This position will ensure that efficacious and safe products are released to the market for sales. It covers the scope of Production Quality, Documentation System, Deviation Investigation and Quality Management System continuous improvement, to ensure the systems compliance with all Domestic and Global regulatory and corporate requirements.

The Main Tasks will be as below:

• To coordinate and ensure timely releasing of incoming materials.
• Responsible for shop floor inspection and control for the whole production process to ensure the whole production process control can meet with site procedures
• Product Release: Review quality control documents, e.g. batch manufacturing records, packaging records and associated documentation in support of batch disposition. Make decisions to release or reject in–process material and final products.
• Deviation investigation: To overall organize and coordinate site deviations investigating and handling.
• Participate the management of routine quality affairs: including the handling of change control, customer complaints and investigation of other quality issues.
• Work with QA team to perform continuous improvement to ensure site can meet all Customer & quality requirements.
• Support for quality related tasks of transferring products from different giving sites to Life Science Nantong.
• Complete other QA related work assigned by QA manager.
• Be a valuable team member of Quality organization through close teamwork and cross functional/sectional activities.
  

Who you are:

• Education:
  • BS in Pharmaceutical/ Chemistry or equivalent.
  
  

• Working Experience:
  • Minimum 5 years of working experience in an international pharmaceutical or biological GMP/ISO environment with GMP/ISO experience. Aseptic experience is preferred.
  • Good experience in product release.
  • Good experience in deviations investigation and root cause analysis.
  • Experience of E-Quality System like Trackwise, FirstDoc or SAP system is preferred
  • Experience of customer audit is preferred.
    
• Technical & Professional Knowledge:
  • Fluent in English. Good reading, writing and communication skills
  • Can work under pressure, handle and overall manage multiple tasks.
  • Result orientation, accuracy and reliability as a must
  • Excellent communication, problem-solving, planning and organization skills
  
  

Functional Area: Quality