(sr./principal) Chemist-qc

Eli Lilly Eli Lilly · Pharma · Suzhou Manufacturing-苏州工厂, China

This role is for a Chemist-QC at Eli Lilly in Suzhou, China. Responsibilities include performing chemical tests, ensuring compliance with GMP and GQS standards, drafting/revising SOPs, managing various lab samples (excipients, in-process, finished products, stability, complaint), documenting analytical work, managing lab consumables and standards, performing 5S management, leading investigations for lab deviations, managing lab changes, and adhering to HSE procedures. The role also involves assisting with quality system improvements and GLIMS deployment.

What you'd actually do

  1. 负责实验室的化学测试并确保测试行为符合中国 GMP和礼来 GQS601,602,603,604的要求。
  2. 负责起草/修订化学测试相关的 SOP。
  3. 按时完成辅料测试,中控样品测试,成品测试及稳定性样品测试。
  4. 作为实验室发现项/偏差的主调查人,负责实验室分析调查和发现项/偏差的调查。
  5. 负责化学实验室事务的管理。

Skills

Required

  • Chemical testing
  • GMP compliance
  • GQS compliance
  • SOP drafting/revision
  • Sample testing (excipients, in-process, finished product, stability, complaint)
  • Analytical documentation (worksheets, reports)
  • Laboratory management
  • Quality system management
  • Investigation of deviations
  • HSE procedures

Nice to have

  • GLIMS system deployment

What the JD emphasized

  • 中国 GMP
  • 礼来 GQS601,602,603,604
  • GMP
  • GQS
  • GLP
  • HSE