QC Technician - Biological

u5C97u4F4Du63CFu8FF0/Position Brand Description:

u53C2u4E0Eu6D01u51C0u7CFBu7EDFu76D1u6D4Bu548Cu5FAEu751Fu7269u5B9Eu9A8Cu5BA4u7684u6D4Bu8BD5u5E76u786Eu4FDDu76D1u6D4Bu548Cu6D4Bu8BD5u64CDu4F5Cu7B26u5408u4E2Du56FDGMPu548Cu793Cu6765GQSu7684u8981u6C42u3002

Participate in clean utility system monitoring and microbiological lab tests, meanwhile ensure the monitoring and the test operations are complied with both Chinese GMP and Lilly GQS requirements.

u4E3Bu8981u804Cu80FD/Key Objectives/Deliverables

• u6B63u786Eu9075u5B88HSEu89C4u7A0Bu5728u65E5u5E38u5DE5u4F5Cu4E2Du6B63u786Eu7A7Fu6234PPEu3002

u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0 Apply HSE Procedure correctly and wear the expected PPE correctlyu00A0u00A0u00A0

u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0 during work.

• u5728u65E5u5E38u5DE5u4F5Cu4E2Du6B63u786Eu9075u5B88u6570u636Eu5B8Cu6574u6027u8981u6C42u3002

u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0 Apply Data Integrity requirement correctly during work.

• u79EFu6781u4E3Bu52A8u5728u56E2u961Fu5185u548Cu56E2u961Fu5916u5206u4EABu8D28u91CFu548Cu5B89u5168u76F8u5173u7684u4E8Bu9879u3002

u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0 Share event on quality and HSE inside and outside team actively.

• u6267u884Cu6D01u51C0u7CFBu7EDFu8D28u91CFu76D1u6D4Bu5305u62ECu996Eu7528u6C34u3001u7EAFu5316u6C34u3001u6CE8u5C04u7528u6C34u3001u6D01u51C0u84B8u6C7Du548Cu6D01u51C0u538Bu7F29u7A7Au6C14u7CFBu7EDFu3002

  Perform quality monitoring for clean utility systems, including portable water system, purified water system, water for injection system, clean steam system and pharmaceutical compressed air system.

• u6267u884Cu5FAEu751Fu7269u5B9Eu9A8Cu5BA4u7684u653Eu884Cu6D4Bu8BD5u5305u62ECu4F46u4E0Du9650u4E8Eu6C34u7CFBu7EDFu4E2Du63A7u6837u54C1u539Fu6599u548Cu5305u6750u3002

u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0Perform QC microbiological lab release testing, include but not limited

u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0 to: Utility, IPC, excipients and PPC.

• u534Fu52A9u5FAEu751Fu7269u5B9Eu9A8Cu5BA4u76F8u5173u7684u65B9u6CD5u786Eu8BA4u548Cu7814u7A76u5305u62ECu8D77u8349u65B9u6848u6267u884Cu64B0u5199u9A8Cu8BC1u62A5u544Au3002

u00A0u00A0u00A0u00A0u00A0 u00A0u00A0u00A0u00A0 u00A0To assist with method verification and study for microbiological lab testu00A0u00A0

u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0 (including protocol draft, method verification execution, report

u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0 generating).

• u8D1Fu8D23u8D77u8349/u4FEEu8BA2u5FAEu751Fu7269u6D4Bu8BD5u76F8u5173u7684SOPu3002

  Be responsible for the SOP draft/revision in QC microbiological lab.

• u53C2u4E0Eu5FAEu751Fu7269u6D01u51C0u5BA4u7684u7BA1u7406u3002

  Participate in microbiological lab clean room management.

• u53C2u4E0Eu5FAEu751Fu7269u6D4Bu8BD5u76F8u5173u7684u6D88u8017u54C1u8BD5u5242u4EE5u53CAu5168u7403/u672Cu5730u6807u51C6u54C1u8FDBu884Cu7BA1u7406u3002

  Participate in management of consumables, reagents, and global /local standards which related to microbiological lab test.

• u53C2u4E0Eu5FAEu751Fu7269u5B9Eu9A8Cu5BA4u7684u6587u4EF6u7BA1u7406u3002

  Participate in document management for microbiological lab.

• u8D1Fu8D23u5B9Eu9A8Cu5BA4u65E5u5E38u62A5u544Au7684u7B2Cu4E8Cu4EBAu590Du6838u53EFu9009

  To be responsible for the routine lab reports second person verification.

• u8D1Fu8D23u5B9Eu9A8Cu5BA4u65B0u8FDBu4EBAu5458u7684u57F9u8BADu53EFu9009

  Responsible for fresh analystsu2019 training.

• u53C2u4E0Eu5FAEu751Fu7269u5B9Eu9A8Cu5BA4u76845Su7BA1u7406u3002

  Participate in 5S management for microbiological lab.

• u505Au5176u5B83u548Cu8D28u91CFu6709u5173u7684u4E8Bu9879u3002

  To assume other tasks related to Quality.

• u534Fu52A9GLIMSu7CFBu7EDFu5B9Eu65BDu3002

  To assist with GLIMS deployment.

• u534Fu52A9u5B9Eu9A8Cu5BA4u8D28u91CFu4F53u7CFBu7684u6301u7EEDu6539u8FDBu63D0u9AD8u548CGLIMSu7CFBu7EDFu5B9Eu65BD

  To assist with lab quality system continuously improvement and GLIMS deployment.

u57FAu672Cu8981u6C42/Basic Requirements:

• u5927u4E13u53CAu4EE5u4E0Au5B66u5386u836Fu5B66u751Fu7269u5B66u6216u76F8u5173u5B66u79D1u3002

  College degree or above, majored in pharmaceuticals, biological or related sciences.

• u80FDu7528u82F1u8BEDu5199u548Cu8BFBu3002

u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0 Capable of writing and read in English.

u5176u4ED6u8981u6C42/Additional Preferences:

• u4E86u89E3GMP

u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0 Understanding of Good Manufacturing Practices.

u5176u4ED6u4FE1u606F/Other Information:

• u53EFu80FDu9700u8981u52A0u73EDu3002

u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0 Overtime may be required.

• u53EFu80FDu9700u8981u8F6Eu73EDu3002

u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0 Working on shift may be required.