QC工程师-内毒素/DNA方向
勃林格殷格翰投资有限公司ShanghaiUpdate time: May 13,2019
Job Description

Job Responsibilities
  • Conduct routine and complex Microbial testing including sterility for raw materials, packaging materials, intermediates, bulk products and finished products, ensure to complete incoming analytical requests timely
  • Assist to establish Testing Specifications for Raw Materials, Packaging Materials and finished product, and relevant SOPs/Forms according to given instructions, ensure to comply with GMP, regulatory and BI requirements
  • Assist in new analytical method establishment,validation and transfer to ensure efficiency and compliance of analytical method
  • Execute lab equipment qualification and maintenance, ensure to perform all tests smoothly .
  • Update SOP related to Product quality function according to business needs and regular review to ensure comply with GMP and BI global requirement.
  • Perform tests and evaluation for supplier qualification, tests and
  • Maintain and optimize the testing procedure including management of equipment, glassware, reagent etc to continues improve the productivity and cost saving with comply with requirement from SFDA and company.
  • Fulfill the other temporary task assigned by QC Supervisor
  • Conduct professional training programs for new staff in order to ensure skill of new staff can meet requirements.
  • To participate organization activities.
Qualifications
  • Education/Degree Requirements: Bachelor or above
  • Major: Microbiology, Biochemical, Pharmaceutical or related discipline
  • Language skills & proficiency: Good English writing, reading, listening and speaking
  • Required capabilities (skills, experience, competencies): Good knowledge of GMP; Familiar with Ch.P, Ph. Eur and USP; 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 mutilple functions; Good coaching ability; Good time management skill


职能类别: 质量管理/测试工程师(QA/QC工程师)

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