職位描述
職位描述：
QC scientist
Description:
1. In order to ensure product quality in accordance with BI SOP/cGMP/Registered Specification, perform testing of starting material, intermediates and product, deviation handling and equipment and reagent management under corporate management guideline and cGMP regulation.
在公司管理規(guī)范和cGMP法規(guī)要求下進(jìn)行物料及產(chǎn)品的分析化驗(yàn)，偏差調(diào)查，設(shè)備及試劑等的管理確保產(chǎn)品質(zhì)量符合BI標(biāo)準(zhǔn)操作規(guī)程要求，cGMP法規(guī)要求，產(chǎn)品注冊(cè)標(biāo)準(zhǔn)。
2. To obey and improve all procedure to maintain a high quality level and competitive cost. 嚴(yán)格執(zhí)行并持續(xù)改進(jìn)各項(xiàng)標(biāo)準(zhǔn)要求以具有競(jìng)爭(zhēng)力的成本保持產(chǎn)品的高質(zhì)量水平。
3. To ensure QC department to maintain the stable support to Value Stream.
確保QC 部門(mén)給予價(jià)值流運(yùn)行良好的支持。
Duties & Responsibilities:
1. Conduct routine and complex microbial testing for raw materials, packaging materials, intermediates, bulk products and finished products, sampling and testing for purified water ,water for injection and environment monitoring etc. ensure to complete incoming analytical requests timely
進(jìn)行原輔料、包裝材料、中間品、待包裝品和成品的常規(guī)和復(fù)雜的微生物檢測(cè)工作,取樣和檢測(cè)純化水，注射用水和環(huán)境監(jiān)控等，以確保按時(shí)完成來(lái)樣分析任務(wù)。
2. Conduct routine DNA residual testing and sub visible particle testing for drug substance and drug product. ensure to complete incoming analytical requests timely
進(jìn)行原液和成品的DNA殘留和不溶性粒子測(cè)試。確保按時(shí)完成來(lái)樣分析任務(wù)。
3. Establish Testing Specifications for Raw Materials, Packaging Materials and finished product, and relevant SOPs/Forms according to given instructions, ensure to comply with GMP, regulatory and BI requirements
根據(jù)指令建立原輔料和包裝材料的質(zhì)量標(biāo)準(zhǔn),以及相關(guān)的SOP/記錄表,以確保符合GMP、規(guī)章和BI的要求。
4. Participate in new analytical method establishment, validation and transfer to ensure efficiency and compliance of analytical method
參與分析方法的建立，驗(yàn)證和轉(zhuǎn)移, 確保分析方法的有效性及合規(guī)性。
5. Execute lab equipment qualification and maintenance, ensure to perform all tests smoothly
實(shí)施實(shí)驗(yàn)室設(shè)備的確認(rèn)和維護(hù)保養(yǎng),以確保順利進(jìn)行所有檢測(cè)任務(wù)。
6. Assist supervisor to finish quality evaluation of abnormal sample and problem solving with professional knowledge and experience.
運(yùn)用專(zhuān)業(yè)知識(shí)和經(jīng)驗(yàn),協(xié)助主管完成對(duì)異常樣品的質(zhì)量判斷以及特殊的問(wèn)題解決。
7. Update SOP related to Product quality function according to business needs and regular review to ensure comply with GMP and BI global requirement.
根據(jù)業(yè)務(wù)發(fā)展需求和定期審核的要求更新產(chǎn)品質(zhì)量的相關(guān)SOP，符合GMP規(guī)范，集團(tuán)操作規(guī)程等法規(guī)要求。
8. Perform tests and evaluation for supplier qualification, tests and investigation for compliant samples and defected materials in production, handle deviation and OOS investigation
履行涉及供應(yīng)商資質(zhì)的相關(guān)檢測(cè)和評(píng)估，投訴樣品及生產(chǎn)中的缺陷物料的檢測(cè)和調(diào)查, 處理偏差和超規(guī)調(diào)查。
9. Maintain and optimize the testing procedure including management of equipment, glassware, reagent etc to continues improve the productivity and cost saving with comply with requirement from SFDA and company.
維持并優(yōu)化包括設(shè)備，玻璃器皿和試劑等管理在內(nèi)的檢測(cè)流程以確保在符合SFDA 和公司指南的要求下高效，經(jīng)濟(jì)。
10. Fulfill the other temporary task assigned by QC Supervisor
完成QC主管臨時(shí)交付的任務(wù)。
11. Plan and conduct professional training programs for new staff in order to ensure skill of new staff can meet requirements.
確保新員工技能勝任檢測(cè)要求 ，計(jì)劃和實(shí)施新員工專(zhuān)業(yè)技能培訓(xùn)。
Requirements:
1. Finish all tests correctly according to agreed timeline.
按照達(dá)成一致的計(jì)劃及時(shí)正確的完成檢測(cè)放行。
2. All documents are prepared timely and comply with GMP and BI requirement.
文件的準(zhǔn)備及時(shí)合規(guī)；
3. Complete timely
完成的及時(shí)性；
4. Efficiency of the method 方法的有效性；
5. Compliance 合規(guī)性。
6. Activities are delivered according to approved schedule and without any impact to the routine testing.
所有行為按照批準(zhǔn)的計(jì)劃實(shí)施并無(wú)任何對(duì)日常檢測(cè)的影響。
7. Efficiency 有效性
8. Regular SOP review completion timeliness 定期審核完成率
9. Investigation closes on time. 調(diào)查完成及時(shí)率
10. CAPA close on time. CAPA完成及時(shí)率
11. Standardize of Testing Method. Transparency of reagent management.
檢驗(yàn)流程的標(biāo)準(zhǔn)化，試劑管理的透明化。
12. Task Times and effect 任務(wù)次數(shù)及效果
13. Take mentor responsibility internally. 做內(nèi)部導(dǎo)師的職責(zé)。
14. Training efficiency培訓(xùn)有效性
15. Provide positive idea numbers to support the improvement of organization performance.
對(duì)組織績(jī)效的提高提供積極的建議數(shù)
Eligibility Requirements:
1. Bachelor or above, majored in Microbiology, Biochemical, Pharmaceutical or related discipline
本科或以上學(xué)歷，微生物學(xué)、生物化學(xué)、藥學(xué)或相關(guān)專(zhuān)業(yè)
2. Good problem solving skill, communication skill 良好的問(wèn)題解決能力
3. Good skill of aseptic technique 良好的無(wú)菌操作技術(shù)
4. Good knowledge of GMP 良好的GMP相關(guān)知識(shí)
5. Familiar with Ch.P, Ph. Eur and USP 熟悉中國(guó)藥典，歐洲藥典和美國(guó)藥典
6. Good team player 良好的團(tuán)隊(duì)合作
7. Good organizing and communication ability 良好的組織溝通能力
8. Sense of urgency, precision and reliability 緊迫感，不斷進(jìn)取，可信賴(lài)
9. Willing to learn and open to new ideas, constructive thinking, initiative and proactive 坦誠(chéng)，積極進(jìn)取
10. Be able to work under pressure 能承受壓力
11. Can create new idea or innovative method to multiple functions 能對(duì)多項(xiàng)職能進(jìn)行創(chuàng)新
12. Good coaching ability 良好的指導(dǎo)能力
13. Good time management skill良好的時(shí)間管理能力
