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.
在公司管理規范和cGMP法規要求下進行物料及產品的分析化驗，偏差調查，設備及試劑等的管理確保產品質量符合BI標準操作規程要求，cGMP法規要求，產品注冊標準。
2. To obey and improve all procedure to maintain a high quality level and competitive cost. 嚴格執行并持續改進各項標準要求以具有競爭力的成本保持產品的高質量水平。
3. To ensure QC department to maintain the stable support to Value Stream.
確保QC 部門給予價值流運行良好的支持。
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
進行原輔料、包裝材料、中間品、待包裝品和成品的常規和復雜的微生物檢測工作,取樣和檢測純化水，注射用水和環境監控等，以確保按時完成來樣分析任務。
2. Conduct routine DNA residual testing and sub visible particle testing for drug substance and drug product. ensure to complete incoming analytical requests timely
進行原液和成品的DNA殘留和不溶性粒子測試。確保按時完成來樣分析任務。
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
根據指令建立原輔料和包裝材料的質量標準,以及相關的SOP/記錄表,以確保符合GMP、規章和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，驗證和轉移, 確保分析方法的有效性及合規性。
5. Execute lab equipment qualification and maintenance, ensure to perform all tests smoothly
實施實驗室設備的確認和維護保養,以確保順利進行所有檢測任務。
6. Assist supervisor to finish quality evaluation of abnormal sample and problem solving with professional knowledge and experience.
運用專業知識和經驗,協助主管完成對異常樣品的質量判斷以及特殊的問題解決。
7. Update SOP related to Product quality function according to business needs and regular review to ensure comply with GMP and BI global requirement.
根據業務發展需求和定期審核的要求更新產品質量的相關SOP，符合GMP規范，集團操作規程等法規要求。
8. Perform tests and evaluation for supplier qualification, tests and investigation for compliant samples and defected materials in production, handle deviation and OOS investigation
履行涉及供應商資質的相關檢測和評估，投訴樣品及生產中的缺陷物料的檢測和調查, 處理偏差和超規調查。
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.
維持并優化包括設備，玻璃器皿和試劑等管理在內的檢測流程以確保在符合SFDA 和公司指南的要求下高效，經濟。
10. Fulfill the other temporary task assigned by QC Supervisor
完成QC主管臨時交付的任務。
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要求 ，計劃和實施新員工專業技能培訓。
Requirements:
1. Finish all tests correctly according to agreed timeline.
按照達成一致的計劃及時正確的完成檢測放行。
2. All documents are prepared timely and comply with GMP and BI requirement.
文件的準備及時合規；
3. Complete timely
完成的及時性；
4. Efficiency of the method 方法的有效性；
5. Compliance 合規性。
6. Activities are delivered according to approved schedule and without any impact to the routine testing.
所有行為按照批準的計劃實施并無任何對日常檢測的影響。
7. Efficiency 有效性
8. Regular SOP review completion timeliness 定期審核完成率
9. Investigation closes on time. 調查完成及時率
10. CAPA close on time. CAPA完成及時率
11. Standardize of Testing Method. Transparency of reagent management.
檢驗流程的標準化，試劑管理的透明化。
12. Task Times and effect 任務次數及效果
13. Take mentor responsibility internally. 做內部導師的職責。
14. Training efficiency培訓有效性
15. Provide positive idea numbers to support the improvement of organization performance.
對組織績效的提高提供積極的建議數
Eligibility Requirements:
1. Bachelor or above, majored in Microbiology, Biochemical, Pharmaceutical or related discipline
本科或以上學歷，微生物學、生物化學、藥學或相關專業
2. Good problem solving skill, communication skill 良好的問題解決能力
3. Good skill of aseptic technique 良好的無菌操作技術
4. Good knowledge of GMP 良好的GMP相關知識
5. Familiar with Ch.P, Ph. Eur and USP 熟悉中國藥典，歐洲藥典和美國藥典
6. Good team player 良好的團隊合作
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，不斷進取，可信賴
9. Willing to learn and open to new ideas, constructive thinking, initiative and proactive 坦誠，積極進取
10. Be able to work under pressure 能承受壓力
11. Can create new idea or innovative method to multiple functions 能對多項職能進行創新
12. Good coaching ability 良好的指導能力
13. Good time management skill良好的時間管理能力
