QC经理招聘_杭州民生健康药业有限公司最新招聘信息-猎才医药网

QC经理 杭州

杭州民生健康药业有限公司

月薪： 1-1.5万/月

2年经验
本科
招1人
11-09 发布

五险一金
绩效奖金
年终奖金
定期体检
员工旅游
补充医疗保险
餐饮补贴

职位描述

职位描述：岗位职责：1.Implement or monitor quality system, ensure quality system running effectively, compliance to CGMP requirement in QC lab.执行或监督质量体系在QC实验室的运行，确保质量体系被有效运行，符合现行GMP要求。2.Maintain laboratory GMP management system (GMP+HSE+ microbial) to ensure data integrity compliant to GMP requirement and there are no serious defects in GMP audit.维护实验室GMP管理系统（GMP+HSE+微生物），确保数据完整性符合GMP要求，GMP审计无严重缺陷。3.Cooperate test work in new project. Provide professional technical support for process validation, cleaning validation and new product.配合新项目的检验。为工艺验证、清洁验证和新产品注册工作提供专业技术支持。4.Ensure high quality, low cost and timely completion of inspection of raw materials, intermediates, packaging materials, finished products (including the stability of sample) and other relevant inspection such as: process validation, cleaning validation, etc.确保高质量、低成本并及时完成原辅料、中间体、内外包材、成品（包括稳定性样品）以及其他相关检验如：工艺验证、清洁验证等。5.Ensure QC chemical reagent, working standard, specification, test method, etc. compliant to GMP / Pharmacopeia requirement. Lead all staff in QC chemical Lab and microbial Lab to finish test work, issue test result and report确保实验室使用试剂对照品，质量标准检验方法等符合GMP和药典要求。带领所有理化实验室和微生物实验室员工，完成检验工作，出具检验数据和报告6.Organize Analytical instrument / equipment qualification / validation, maintenance and preventative, computerized system and audit trial compliant to GMP requirement.组织实验室分析仪器的确认/验证、维护保养，计算机系统和审计追踪符合GMP要求。7.Management and monitoring of stability programs.稳定性计划的管理和监控。8.Conduct internal audit/ and monitoring progress in related GMP area.执行内部审计和GMP监控。9.Be in charge of investigation on laboratory deviation and OOS/OOT, Quality risk assessment and CAPA track in responsible area.负责实验室偏差、OOS/OOT实验室调查，负责的工作领域进行适时的质量风险评估，CAPA的追踪。10.Closely support for work in other functional department. Participate in product quality improvement.紧密支持其他部门工作。参与产品质量改进。11.Create an open, relax and continues study and work environment in QC department. Train analysts.组建一个开放、积极和持续改进的工作环境。培训检验员。12.Be in charge of the Health-Safety-Environment in his/her position/workstation as the first person.作为第一HSE负责人对职责范围（岗位）内的职业健康安全环境工作负责。13.Complete other work assigned by supervisor.完成上级安排的其它工作。Must to have :最低要求？Education教育: bachelor’ degree 学士学位。？Professional /Major专业： Analytical chemistry or related分析化学或相关专业。？Experience 经验: 8years experience in QC lab ，2 years QC management experience.8年QC工作经验,其中2年以上QC管理经验。？Language语言: Good written and spoken English 良好的英语听说能力。？IT Skill电脑技能: Excel software 会使用EXCEL。？Other Ability其他能力: Good ability to communicate with colleagues.良好的沟通能力。职能类别：质量管理/测试经理(QA/QC经理) 药品生产/质量管理关键字： QC 药品生产质量检测控制经理医药测试