職位描述
POSITION SUMMARY（職位概述）
Plan and conduct micro analysis/test and documentation required by control plan/SOPs for raw materials, finished product, utilities, environmental and other necessary. Take main responsibility for micro analysis relevant implemented to meet corporate/ISO/GB/regulation/GMP requirements.
計(jì)劃、執(zhí)行微生物實(shí)驗(yàn)室分析和測(cè)試，包括原料、成品、公用設(shè)施、環(huán)境和其他必要的測(cè)試。確保相關(guān)微生物分析測(cè)試符合公司/ISO/GB/法規(guī)/GMP的要求。
KEY RESPONSIBILITIES（主要職責(zé)）
1. Set up the management rules to ensure the efficiency of laboratory work under the well compliance with the corporate/ISO/GB/regulation/GMP requirements.
建立微生物實(shí)驗(yàn)室管理規(guī)程確保實(shí)驗(yàn)室的有效運(yùn)行，并符合公司/ISO/GB/法規(guī)/GMP的要求。
2. Perform qualification/validation/calibration and maintenance for analytical devices to ensure analytical devices in good status and GMP compliance.
執(zhí)行分析設(shè)備/儀器的確認(rèn)/驗(yàn)證/校驗(yàn)和維護(hù)以確保分析設(shè)備/儀器處于良好的狀態(tài)和GMP的符合性。
3. Plan and execute the microbiological limits test/sterility test/Endotoxin test method validation.
計(jì)劃和執(zhí)行完成微生物限度檢查、無(wú)菌檢驗(yàn)、細(xì)菌內(nèi)毒素測(cè)試的方法驗(yàn)證。
4. Perform and record microbiological testing for raw material, packaging material, products, stability, utilities, environmental sample by following Quality Specification /control plan, to provide accurate testing results on time
依據(jù)質(zhì)量標(biāo)準(zhǔn)/檢驗(yàn)計(jì)劃完成原料、包裝材料、產(chǎn)品、穩(wěn)定性、公用設(shè)施、環(huán)境等的微生物測(cè)試，并及時(shí)提供準(zhǔn)確的檢驗(yàn)數(shù)據(jù)。
5. Handle chemical reagents, biological reference substances/standard strains and solutions appropriate to compliance with the regulations and SOPs, to keep safe and tidiness of working area.
依據(jù)法規(guī)和SOPs要求操作化學(xué)品、微生物參考物質(zhì)/標(biāo)準(zhǔn)菌株、溶液等，確保實(shí)驗(yàn)室安全和工作區(qū)域的整潔。
6. Cope with abnormities of the testing in time by reporting to the supervisor, or appropriate to the instruction of SOP.
及時(shí)調(diào)查實(shí)驗(yàn)室測(cè)試異常結(jié)果的調(diào)查。
7. Leading and working on OOS investigation for microbial results of water/raw material, products.
領(lǐng)導(dǎo)水、原料、產(chǎn)品微生物檢驗(yàn)的任何OOS的調(diào)查活動(dòng)。
8. As a microbiological expert provide training to production, involve in relevant deviation investigation.
作為微生物專家給生產(chǎn)部提供相關(guān)微生物培訓(xùn)、參與相關(guān)偏差調(diào)查。
9. Perform the annual products sterilization validation and report all the validation testing.
參與產(chǎn)品的年度滅菌確認(rèn)并負(fù)責(zé)產(chǎn)品驗(yàn)證時(shí)實(shí)驗(yàn)的組織和結(jié)果的控制;
10. Plan and reviewing the inventory of reagent, glassware and miscellaneous items in microbiological laboratory and make order plans based on the budgets.
計(jì)劃微生物實(shí)驗(yàn)室試劑、玻璃儀器、耗材的采購(gòu)和維護(hù)適當(dāng)?shù)膸?kù)存管理。
11. Other work need to do.
任何其他安排的工作。
SKILLS AND ABILITIES（技能）
1. Above bachelor degree of microbiological, or relevant.
微生物或相關(guān)專業(yè)，本科或以上學(xué)歷畢業(yè)；
2. 3 years’ experience for micro analysis.
相關(guān)微生物工作經(jīng)驗(yàn)3年以上；
3. GMP/ISO13485 knowledge as basic for the role
具備GMP/ISO 13485相關(guān)知識(shí)
4. Good communicate and learning skill.
良好的溝通技巧、學(xué)習(xí)能力；
5. Skill of Microsoft office .
電腦辦公軟件應(yīng)用熟練；
6. Skill of English in reading and writing.
有一定的英語(yǔ)讀寫(xiě)能力。
7. With or be trained Pressure Vessel Operation Certificate preferred
持有壓力容器操作證，或經(jīng)相關(guān)培訓(xùn)
