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-Manages Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems

Major Accountabilities

1）Ensure and support the quality system and related tools been setup, carried out and properly maintained, to meet with the regulatory changes and business development.

在快速更新的法規(guī)環(huán)境和業(yè)務(wù)迅速發(fā)展變革的環(huán)境下,，確保和支持質(zhì)量體系及相關(guān)管理工具的建立,，執(zhí)行和相應(yīng)的維護(hù)。

2） Track China GxP Regulatory intelligence, lead regulation gap assessment and coordinate the regulation implementation with relevant functions.

跟蹤中國(guó)GxP法規(guī)更新,，負(fù)責(zé)法規(guī)差距評(píng)估,，并協(xié)調(diào)相關(guān)部門實(shí)施法規(guī)要求。

3） Responsible for Novartis vendor management and ensure control of third parties by regular inspections and follow ups. Participate in global GMP/GSP audits at China CPO operations and supervision of follow-up action plans.

負(fù)責(zé)諾華供應(yīng)商管理,，確保第三方定期審計(jì)和CAPA的及時(shí)跟蹤,。參與總部GMP/GSP的審計(jì)并跟蹤后續(xù)整改措施的完成。

4） Ensure that appropriate, accurate & up-to–date signed quality agreements with third parties are in place for all GMP/GSP activities.

確保適當(dāng),、及時(shí),、準(zhǔn)確地與供應(yīng)商簽署質(zhì)量協(xié)議來(lái)規(guī)范其GMP/GSP操作。

5） Responsible for GOP implementation at local level and documentation management, cooperate with functions/ESOPS manager for SOP/WP lifecycle management.

負(fù)責(zé)總部GOP在本地的實(shí)施,，文檔的管理,，與各部門/ESOPS管理員協(xié)作確保流程文件的制定、批準(zhǔn),、生效,、保存等。

6）Responsible for training management such as training matrix, ensure GxP personnel training comply with Novartis and local regulation requirements.

負(fù)責(zé)培訓(xùn)體系例如管理培訓(xùn)矩陣,，確保GxP 人員培訓(xùn)符合諾華和當(dāng)?shù)胤ㄒ?guī)的要求,。

7）Participate e-system / digital tools roll out and upgradation, and ensure compliance to Novartis and local regulation requirements at GxP area.

參與電子系統(tǒng)/數(shù)據(jù)工具的實(shí)施和升級(jí)，確保GxP相關(guān)的計(jì)算機(jī)系統(tǒng)符合諾華和當(dāng)?shù)胤ㄒ?guī)的要求,。

8）Manage QM/QD implementation that ensures continuous compliance with Novartis global Quality Manual and local regulatory requirements.

管理質(zhì)量手冊(cè)/質(zhì)量指導(dǎo)的實(shí)施,，確保持續(xù)的符合諾華總部質(zhì)量手冊(cè)和本地法規(guī)的要求。

9）Lead/support global or local quality project.

負(fù)責(zé)或支持總部或本地質(zhì)量部項(xiàng)目,。

10）Provide effective compliance supports and services to other functions.

提供對(duì)其他部門有效的合規(guī)支持和服務(wù),。

Key Performance Indicators

Ensure NCQ KQIs of the GMP/GSP part.

確保GMP/GSP 部分的 NCQ KQI 。

CAPA follow-up, no overdue occurs on the Inspection, Audit, Q-plan and Country Organization Risk Assessment related CAPA plan.

確保在檢查,，審計(jì),，質(zhì)量計(jì)劃和風(fēng)險(xiǎn)評(píng)估中的CAPA及時(shí)追蹤，沒(méi)有超期,。

Vendor management, up-to-date signed QAA with third parties.

供應(yīng)商管理,，及時(shí)更新與第三方的質(zhì)量協(xié)議。

Ensure China GxP Regulatory intelligence and compliance.

確保中國(guó)GxP法規(guī)更新及時(shí)實(shí)施和合規(guī),。

Ensures Novartis global Quality Manual and GOP implementation.

確保持續(xù)的符合諾華總部質(zhì)量手冊(cè)和管理流程的實(shí)施,。

Work Experience

教育 : Bachelor degree above, pharmaceutical major relevant, license pharmacist is preferred 醫(yī)藥相關(guān)專業(yè)本科以上學(xué)歷，執(zhí)業(yè)藥師優(yōu)先

語(yǔ)言: Effective oral and written abilities in English. 流暢的英文口語(yǔ)和書寫能力

經(jīng)驗(yàn):

At least 3 years working experiences in QA function or GMP/GSP related experiences in pharmaceutical joint venture.

至少3年制藥領(lǐng)域GMP/GSP QA相關(guān)工作經(jīng)驗(yàn),。

Be familiar with the law for pharmaceutical manufacturing and in-depth understanding of current GMP/GSP.

熟悉藥品生產(chǎn)相關(guān)法律法規(guī),，深刻理解現(xiàn)行GMP/GSP,。

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Technological Expertise

Self-Awareness

Continued Learning

Quality Management

Good Documentation Practice

Regulation

Guideline

Knowledge Of Capa

Qa (Quality Assurance)

Dealing With Ambiguity