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職位概要(Job summary):
新項(xiàng)目開(kāi)發(fā)的品質(zhì)保證。
Quality assurance for new project quality development.
工作職責(zé)(Responsibilities):
1. 制定新項(xiàng)目導(dǎo)入的品質(zhì)保證和合規(guī)性要求，并審閱和修訂相關(guān)的質(zhì)量協(xié)議和合規(guī)性聲明及產(chǎn)品注冊(cè)要求；
Set the quality assurance and regulatory compliance request for new project transfer, review and revision the related quality agreement and compliance certification and registration request.
2. 參與新產(chǎn)品過(guò)程開(kāi)發(fā)，識(shí)別各過(guò)程中的風(fēng)險(xiǎn)并制定風(fēng)險(xiǎn)控制措施；
Take part in new process development for new product, identify the risks from the new process and define proper activities to control the risks.
3. 參與制定過(guò)程驗(yàn)證主計(jì)劃并審核OQ和PQ，確保過(guò)程風(fēng)險(xiǎn)點(diǎn)被有效驗(yàn)證；
Participate to create VMP (validation Master Plan), and review OQ (Operation Qualification) and PQ (Performance Qualification) to ensure all risks be validated effectively.
4. 制定產(chǎn)品外觀標(biāo)準(zhǔn)并與客戶達(dá)成一致；
To align cosmetic criteria with customer.
5. 建立產(chǎn)品測(cè)試方法并實(shí)施TMV (Test Method Validation)；
Establish specific test method for product and implement TMV.
6. 建立適當(dāng)?shù)能囬g環(huán)境及微生物控制流程以滿足產(chǎn)品滅菌要求；
Establish control procedure for new product to meet sterilization requirement.
7. 建立過(guò)程控制計(jì)劃以及相關(guān)檢驗(yàn)WI；
Create process control plan and related work instruction for inspection.
8. 建立物料可接受標(biāo)準(zhǔn)，并完成物料檢驗(yàn)WI；
Align material acceptance criteria, and establish work instruction for incoming material.
9. 評(píng)估供應(yīng)商的測(cè)試方法和驗(yàn)證結(jié)果；
Align test/inspection method with vendor, such as tooling selection, TMV protocol, etc.
10. 確認(rèn)打樣物料的符合性。
Verify if incoming materials meet the requirements, which are for prototype sample building.