招聘岗位:QC Scientist (Biopharma) / QC 研究员
Basic Purpose of the Position 岗位的基本目标
1. Perform testing of raw material and biological APIs and Drug Product, deviation investigations and equipment and reagent management under company’s guideline and cGMP regulation. Ensure the accuracy and reliability of test results to assure product quality and support production and registration. 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。确保检验数据准确可靠,科学反映产品的质量特征,从而支持生产及产品注册。
2. To comply and improve each procedure to maintain a high efficiency with reliability under a 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检验的高效可靠。
Accountabilities 职责
1. Responsible for arranging and carrying out testing for raw materials, packaging materials, intermediates, bulk products and finished products, testing for pharmaceutical water. Ensure to complete incoming analytical requests accurately and timely 负责组织及实施原辅料、包装材料、中间品、待包装品和成品的检测工作。确保按时完成样品检测。
2. Participate into establish testing Specifications for product, raw materials and packaging materials, and relevant SOPs/Forms according to given instructions, ensure to comply with GMP, regulatory and BI requirements 参与建立产品,原辅料,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
3. 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
4. Participate in analytical method transferring and validation. 参与产品分析方法转移和验证 。
5. Participate in OOS investigation. 参与调查处理超标结果。
6. Maintain the equipment, glassware, reagent etc. in productivity and cost saving status meanwhile complies with requirement from SFDA and company. 维持设备,玻璃器皿和试剂等管理以确保在符合SFDA 和公司指南的要求下高效,经济。
7. Follow related SOPs and regulations strictly in lab. 严格执行实验室的相关标准作业程序和规章制度
8. Fill in related documentation such as BAR, other logbook etc., timely to ensure the reliability of content as per requirement of SOPs. 及时按照SOP的要求填写相关文件记录如批检验记录、仪器使用和维护记录等并保证内容的真实可靠。
9. Take part in actively in correction to the observations found in self-inspection. 积极参加对自检中所发现缺陷的整改
10. Participate actively in serials training required to be held by internal and external. 积极参加由内部或外部组织的系列培训活动。
11. Develop all kinds of skills in relation to work field and pursue continuous improvement 发展各种工作技能并追求持续的改进 Required Experience 所需的工作经验背景 At least 3 years’ experience in Quality Control in the biopharmaceutical or pharmaceutical industry. Have experience in raw material test; Familiar with HPLC, GC application in protein or chemical analysis; Multinational pharmaceutical company experience is preferred. 至少有3年以上生物医药或化学医药行业工厂QC工作经验。具有原辅料检验经验;熟悉HPLC, ELISA等在蛋白质或化药分析中的应用;跨国制药企业经验优先考虑。
Degree / Education 学位/教育
Bachelor or above, Bio Chemistry/Pharmaceuticals/Instrument analysis 学士及以上,生物制药或仪器分析相关专业
Required Capabilities (Skills, Experience, Competencies) 所需的能力(技能、经验、胜任能力)
1. Good knowledge of GMP 良好的GMP相关知识
2. Familiar with related local regulations 熟悉当地相关法规
3. Good team player 良好的团队合作
4. Good organizing and communication ability 良好的组织沟通能力
5. Sense of urgency, precision and reliability 紧迫感,不断进取,可信
6. Willing to learn and open to new ideas, constructive thinking, initiative and proactive 坦诚,积极进取
7. Be able to work under pressure 能承受压力
8. Can create new idea or innovative method to mutilple functions 能对多项职能进行创新
9. Good coaching ability 良好的指导能力
10. Good time management skill良好的时间管理能力