Job Responsibilities/工作職責(zé)

1. Participate in the material release activity.

物料放行工作。

2. Participate in the compliance review of Material Management related GMP documents and records.

參與物料管理相關(guān)GMP文件和記錄的合規(guī)性審核。

3. Participate in the handling of Material Management related quality events, including deviation, change control, CAPA,
etc.

參與物料管理相關(guān)質(zhì)量事件的處理，包括偏差、變更、糾正與預(yù)防措施等。

4. Oversee GMP compliance of the operation and site management of Material Management.

監(jiān)督物料管理的操作和現(xiàn)場管理的GMP合規(guī)性。

5. Review relevant qualification/validation protocol and report.

審核相關(guān)確認(rèn)/驗證方案和報告。

6. Participate in the internal audit (self-inspection), external audit and supplier audit.

參與內(nèi)審（自檢）、外審和供應(yīng)商審計。

7. Complete the other QA tasks as assigned.

完成分配的其他QA工作。

Job Requirements/崗位要求

1. College degree or equivalent and above, major in Biology or Pharmacy is preferred.

?？萍耙陨匣蛲葘W(xué)歷，生物或制藥相關(guān)專業(yè)優(yōu)先。

2. Experience in a quality regulated industry, pharmaceutical or medical device is preferred.Experience in the biologic quality environment is a plus.

有質(zhì)量監(jiān)管行業(yè)、制藥或醫(yī)療器械經(jīng)驗者優(yōu)先。有生物質(zhì)量環(huán)境經(jīng)驗者優(yōu)先。

3. Proficiency in the use of common Microsoft Office Applications.

熟練使用常用Microsoft Office應(yīng)用程序。

4. Have knowledge of GMPs and related guidelines and regulatory requirements.

了解GMP及相關(guān)指南和法規(guī)要求。

5. Good written and oral English skills is preferred.

書面和口語英語優(yōu)秀者優(yōu)先。