职位描述
职位描述：
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.
在公司管理规范和cGMP法规要求下进行物料及产品的分析化验，偏差调查，设备及试剂等的管理确保产品质量符合BI标准操作规程要求，cGMP法规要求，产品注册标准。
2. To obey and improve all procedure to maintain a high quality level and competitive cost. 严格执行并持续改进各项标准要求以具有竞争力的成本保持产品的高质量水平。
3. To ensure QC department to maintain the stable support to Value Stream.
确保QC 部门给予价值流运行良好的支持。
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
进行原辅料、包装材料、中间品、待包装品和成品的常规和复杂的微生物检测工作,取样和检测纯化水，注射用水和环境监控等，以确保按时完成来样分析任务。
2. Conduct routine DNA residual testing and sub visible particle testing for drug substance and drug product. ensure to complete incoming analytical requests timely
进行原液和成品的DNA残留和不溶性粒子测试。确保按时完成来样分析任务。
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
根据指令建立原辅料和包装材料的质量标准,以及相关的SOP/记录表,以确保符合GMP、规章和BI的要求。
4. Participate in new analytical method establishment, validation and transfer to ensure efficiency and compliance of analytical method
参与分析方法的建立，验证和转移, 确保分析方法的有效性及合规性。
5. Execute lab equipment qualification and maintenance, ensure to perform all tests smoothly
实施实验室设备的确认和维护保养,以确保顺利进行所有检测任务。
6. Assist supervisor to finish quality evaluation of abnormal sample and problem solving with professional knowledge and experience.
运用专业知识和经验,协助主管完成对异常样品的质量判断以及特殊的问题解决。
7. Update SOP related to Product quality function according to business needs and regular review to ensure comply with GMP and BI global requirement.
根据业务发展需求和定期审核的要求更新产品质量的相关SOP，符合GMP规范，集团操作规程等法规要求。
8. Perform tests and evaluation for supplier qualification, tests and investigation for compliant samples and defected materials in production, handle deviation and OOS investigation
履行涉及供应商资质的相关检测和评估，投诉样品及生产中的缺陷物料的检测和调查, 处理偏差和超规调查。
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.
维持并优化包括设备，玻璃器皿和试剂等管理在内的检测流程以确保在符合SFDA 和公司指南的要求下高效，经济。
10. Fulfill the other temporary task assigned by QC Supervisor
完成QC主管临时交付的任务。
11. Plan and conduct professional training programs for new staff in order to ensure skill of new staff can meet requirements.
确保新员工技能胜任检测要求 ，计划和实施新员工专业技能培训。
Requirements:
1. Finish all tests correctly according to agreed timeline.
按照达成一致的计划及时正确的完成检测放行。
2. All documents are prepared timely and comply with GMP and BI requirement.
文件的准备及时合规；
3. Complete timely
完成的及时性；
4. Efficiency of the method 方法的有效性；
5. Compliance 合规性。
6. Activities are delivered according to approved schedule and without any impact to the routine testing.
所有行为按照批准的计划实施并无任何对日常检测的影响。
7. Efficiency 有效性
8. Regular SOP review completion timeliness 定期审核完成率
9. Investigation closes on time. 调查完成及时率
10. CAPA close on time. CAPA完成及时率
11. Standardize of Testing Method. Transparency of reagent management.
检验流程的标准化，试剂管理的透明化。
12. Task Times and effect 任务次数及效果
13. Take mentor responsibility internally. 做内部导师的职责。
14. Training efficiency培训有效性
15. Provide positive idea numbers to support the improvement of organization performance.
对组织绩效的提高提供积极的建议数
Eligibility Requirements:
1. Bachelor or above, majored in Microbiology, Biochemical, Pharmaceutical or related discipline
本科或以上学历，微生物学、生物化学、药学或相关专业
2. Good problem solving skill, communication skill 良好的问题解决能力
3. Good skill of aseptic technique 良好的无菌操作技术
4. Good knowledge of GMP 良好的GMP相关知识
5. Familiar with Ch.P, Ph. Eur and USP 熟悉中国药典，欧洲药典和美国药典
6. Good team player 良好的团队合作
7. Good organizing and communication ability 良好的组织沟通能力
8. Sense of urgency, precision and reliability 紧迫感，不断进取，可信赖
9. Willing to learn and open to new ideas, constructive thinking, initiative and proactive 坦诚，积极进取
10. Be able to work under pressure 能承受压力
11. Can create new idea or innovative method to multiple functions 能对多项职能进行创新
12. Good coaching ability 良好的指导能力
13. Good time management skill良好的时间管理能力
