要求：

(a) Academic / Major學(xué)歷 /專業(yè)

Bachelor degree or above in Medical, Pharmacology or Biology related major.

醫(yī)學(xué)、藥學(xué)及生物學(xué)相關(guān)專業(yè)本科以上學(xué)歷。

(b) Professional Skills專業(yè)技能要求

Adequate knowledge of new drug development, clinical operation, local regulation, GCP & Chinese GCP. Got GCP certificate.

掌握藥物開發(fā)、臨床試驗(yàn)流程，熟悉相關(guān)法規(guī)，GCP&中國(guó) GCP，并獲得GCP 證書。

(c) Working Experience 工作經(jīng)驗(yàn)要求

At least 2 years QA & Training working experience; experience global company audit is preferred.

至少兩年QA 或培訓(xùn)工作經(jīng)驗(yàn)；有跨國(guó)企業(yè)工作經(jīng)歷者優(yōu)先。

(d) Language ability 語言能力

Fluent in both written and oral English.

流利的英語書寫和口語能力。

(e) Computer Literacy 電腦相關(guān)知識(shí)

Good at Microsoft offices.

擅長(zhǎng)微軟辦公軟件。

(f) Other abilities such as Communication skills\Information-gathering skills 本職位要求的其他能力：如溝通能力\信息收集能力等

NA

(g) Tigermed Cultural Requirements 泰格的文化要求

Integrity, honesty and professionalism. 正直誠(chéng)信、實(shí)事求是、敬業(yè)合作。


一、 Responsibilities 工作職責(zé)
(a) 建立、修改、更新并完善SOPs 及維護(hù)、管理SOPs SOP management
1.建立及完善英放SOP。
Set up and develop FAB SOP.
2.根據(jù)SOP 要求，協(xié)助定期審閱SOP 是否符合現(xiàn)行操作及法規(guī)。
According to SOP, Periodically review SOP and check if it comply with the existing regulatory requirements and operation procedure.
3.確保與泰格總體SOP 一致性，并補(bǔ)充完善醫(yī)學(xué)影像特殊要求所需的SOPs。
Ensure consistency with the Tigermed general SOP and develop the specific SOPs which are applicable for imaging CRO practice.
(b)為保證質(zhì)量體系而進(jìn)行的稽查活動(dòng)
Audit activities for QMS assurance
1.為保證臨床試驗(yàn)質(zhì)量，定期對(duì)英放內(nèi)部臨床試驗(yàn)項(xiàng)目的操作和管理進(jìn)行稽查。參與公司內(nèi)部稽查計(jì)劃制定、執(zhí)行與遞交稽查報(bào)告。
To ensure trial quality, periodically conduct audit for clinical trial operation and management. To involve in developing internal audit plan, implementation and issue audit report
2.審閱所有稽查報(bào)告的回復(fù)及跟進(jìn)，并匯總稽查問題，給項(xiàng)目組成員進(jìn)行培訓(xùn)。
Review and tracking all the audit response report and provide training to project team member in terms of audit findings.
3.履行合同外部稽查 contractual external audit.
4.負(fù)責(zé)和泰格QA 溝通、交流和協(xié)調(diào)。
Responsible for communication and coordination with QA team of Tigermed.
(c)對(duì)員工的培訓(xùn)
Staff Training
1.對(duì)新入職相關(guān)人員進(jìn)行SOP 培訓(xùn)。
Provide SOPs training to new staff.
2.指導(dǎo)各部門SOP 培訓(xùn)，并建立員工培訓(xùn)記錄，定期對(duì)這些記錄進(jìn)行檢查，確保更新及完整。Guide and nominate each department to deliver SOP training as well as set up personnel training record and periodically checking to ensure updating & integrity.
3.制定月培訓(xùn)計(jì)劃，負(fù)責(zé)執(zhí)導(dǎo)或協(xié)調(diào)各部門相關(guān)人員給予員工進(jìn)行技能提升培訓(xùn)
Make monthly training plan and conduct training or coordinate with relevant department to nominate person to provide training.
4.負(fù)責(zé)將英放周及月培訓(xùn)的課件進(jìn)行存檔并保管。
Resposible for archiving and uploading files to designated folders of FAB/Tigermed;
(d)協(xié)助完成，但不局限于，商業(yè)發(fā)展部安排的指定任務(wù)
Assist other assignments from Business Development Dept.
1.開票、款項(xiàng)跟進(jìn)、付款等。
Invoices、tracking、payment.
2.協(xié)助完成軟件著作權(quán)、政府基金的申請(qǐng)工作。
Assist the application of software copyright and the government fund.
3.協(xié)助總經(jīng)理規(guī)劃、協(xié)調(diào)、掌握公司項(xiàng)目進(jìn)程的全貌，進(jìn)行資源合理調(diào)配和安排；
Assist General Manager to oversee the progress of ongoing projects, outline the risk management and preventive measures, coordinate resources to smoothen the project running;
4.協(xié)助PM 協(xié)調(diào)獨(dú)立閱片者的安排
Assist Project Manager to coordinate the arrangement of independent reviewers.