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Head of QC
1-2K/月湖北省-武汉/本科及以上/5-10年
姚婉琳一周前来过
广州市君信药业有限公司
职位详情
岗位职责
工作职责：
1. Management duties 管理责任:
· Operational, i.e. personnel, technical and financial lead of the Quality Control Laboratories:
负责QC实验室的运营，比如人员，技术及成本等。
· Live CSL Values and implement CSL Guidelines
遵循CSL的价值观并贯彻CSL各项指导原则
· Achieve approved divisional targets
达成批准的部门责任目标
· Plan and supervise of optimal use of resources (staff, material, equipment and rooms) to ensure efficiency and achievement of targets
计划并督促合理安排使用各种资源（人员，物料，设备和场地），使之能有效地达成相关目标。
· Development of staff through training, further education and delegation of duties
通过培训、教育及工作代理等方式培养人才成长。
· Encourage and facilitate team spirit and motivation of staff by means of regular positive and negative feedback
了解员工的正反两方面的反馈，鼓舞提升员工士气。
· Evaluation of department’s target achievements and performance evaluation of direct reports regularly
定期评估部门及直接下属的目标达成情况。
· Generate and actively manage further education planning and position descriptions of direct reports
制定管理直接下属的岗位职责和再培训计划。
· Generate and achieve department budget
制定并达成部门财务预算目标。
· Ensure meet data integrity requirements in whole data life cycle. Be responsible for data integrity in QC.
确保满足产品生命周期数据可靠性的客观要求，对组织内数据可靠性负有最终责任。
· Nurture efficient Communication
促进有效沟通:
· Regularly inform superior about current business as well as problems within division.
定期向上级汇报目前工作情况及部门内存在的需要改进的地方。
· Ensure that staff and colleagues, as well as customers always receive the appropriate and required information
确保部门人员、同事及客户能收到合适及需要的信息。
2. Technical duties 技术责任:
· Professional and timely completion of the microbiological and biological, chemical and biochemical analytics (final products, plasma, intermediates, raw materials, environment, utilities, disinfectants, cleaning processes etc.) and associated support activities such as sample logistics and documentation
及时专业完成微生物、生物、化学、生物化学相关检验（成品、血浆、中间产品、原材料、环境、公用系统、消毒剂、清洁过程等）及相关工作，比如样品收发及记录，负责检验各结果的审核和检验报告的签发。
· Consistent, professional and timely capture and editing of OOT/OOS-results and deviations. Finish investigation timely.
持续、专业、及时发现并记录OOT/OOS和偏差，并及时完成相关调查
· Professional and timely generation and editing of the QC owned SOP’s
专业及时完成QC 的SOP的制定、修订。
· Professional and timely evaluation, development, validation and re-validation of microbiological and biological, chemical and biochemical analytical test procedures
专业及时评估、开发、验证和再验证微生物、生物、化学及生物化学分析方法。
· Professional and timely evaluation, procurement, qualification, re-qualification, maintenance, calibration and monitoring of the divisional equipment
专业、及时评估购买、确认、再确认、维护、校验和巡查部门仪器。
· Establish and maintain contacts with external partners, (contract laboratories, technical high schools and universities, expert groups etc.) together with participation and evaluation of external inter-laboratory tests such as national and international studies
建立和维护联系外部专业资源（第三方实验室、高校、行业专家等），参与与国内外实验室之间的实验评估。
· Collaboration in resolution of technical problems or questions (quality problems, questions from authorities etc.)
在解决技术问题及事件（质量事件、监管机构提出的问题等）上与其他部门协作。
· Respect the CSL Guidelines regarding health, safety and environment
遵守CSL EHS 相关要求。
任职要求：
· Degree (Bachelor or higher) in Biology, Microbiology, Chemistry or related Life Sciences
生物学，微生物学，化学及相关专业本科以上学历
· Team leadership
团队领导能力
· Proven experience in Quality Control processes in a medical or pharmaceutical GMP regulated environment
具有医药行业GMP环境下质量控制管理经验
· Good technical understanding of QC test methods and analytical equipment.
充分了解QC检验方法及分析仪器
· Languages: English fluent, written and spoken
语言能力： 流利的英语读、写、说能力
1. Management duties 管理责任:
· Operational, i.e. personnel, technical and financial lead of the Quality Control Laboratories:
负责QC实验室的运营，比如人员，技术及成本等。
· Live CSL Values and implement CSL Guidelines
遵循CSL的价值观并贯彻CSL各项指导原则
· Achieve approved divisional targets
达成批准的部门责任目标
· Plan and supervise of optimal use of resources (staff, material, equipment and rooms) to ensure efficiency and achievement of targets
计划并督促合理安排使用各种资源（人员，物料，设备和场地），使之能有效地达成相关目标。
· Development of staff through training, further education and delegation of duties
通过培训、教育及工作代理等方式培养人才成长。
· Encourage and facilitate team spirit and motivation of staff by means of regular positive and negative feedback
了解员工的正反两方面的反馈，鼓舞提升员工士气。
· Evaluation of department’s target achievements and performance evaluation of direct reports regularly
定期评估部门及直接下属的目标达成情况。
· Generate and actively manage further education planning and position descriptions of direct reports
制定管理直接下属的岗位职责和再培训计划。
· Generate and achieve department budget
制定并达成部门财务预算目标。
· Ensure meet data integrity requirements in whole data life cycle. Be responsible for data integrity in QC.
确保满足产品生命周期数据可靠性的客观要求，对组织内数据可靠性负有最终责任。
· Nurture efficient Communication
促进有效沟通:
· Regularly inform superior about current business as well as problems within division.
定期向上级汇报目前工作情况及部门内存在的需要改进的地方。
· Ensure that staff and colleagues, as well as customers always receive the appropriate and required information
确保部门人员、同事及客户能收到合适及需要的信息。
2. Technical duties 技术责任:
· Professional and timely completion of the microbiological and biological, chemical and biochemical analytics (final products, plasma, intermediates, raw materials, environment, utilities, disinfectants, cleaning processes etc.) and associated support activities such as sample logistics and documentation
及时专业完成微生物、生物、化学、生物化学相关检验（成品、血浆、中间产品、原材料、环境、公用系统、消毒剂、清洁过程等）及相关工作，比如样品收发及记录，负责检验各结果的审核和检验报告的签发。
· Consistent, professional and timely capture and editing of OOT/OOS-results and deviations. Finish investigation timely.
持续、专业、及时发现并记录OOT/OOS和偏差，并及时完成相关调查
· Professional and timely generation and editing of the QC owned SOP’s
专业及时完成QC 的SOP的制定、修订。
· Professional and timely evaluation, development, validation and re-validation of microbiological and biological, chemical and biochemical analytical test procedures
专业及时评估、开发、验证和再验证微生物、生物、化学及生物化学分析方法。
· Professional and timely evaluation, procurement, qualification, re-qualification, maintenance, calibration and monitoring of the divisional equipment
专业、及时评估购买、确认、再确认、维护、校验和巡查部门仪器。
· Establish and maintain contacts with external partners, (contract laboratories, technical high schools and universities, expert groups etc.) together with participation and evaluation of external inter-laboratory tests such as national and international studies
建立和维护联系外部专业资源（第三方实验室、高校、行业专家等），参与与国内外实验室之间的实验评估。
· Collaboration in resolution of technical problems or questions (quality problems, questions from authorities etc.)
在解决技术问题及事件（质量事件、监管机构提出的问题等）上与其他部门协作。
· Respect the CSL Guidelines regarding health, safety and environment
遵守CSL EHS 相关要求。
任职要求：
· Degree (Bachelor or higher) in Biology, Microbiology, Chemistry or related Life Sciences
生物学，微生物学，化学及相关专业本科以上学历
· Team leadership
团队领导能力
· Proven experience in Quality Control processes in a medical or pharmaceutical GMP regulated environment
具有医药行业GMP环境下质量控制管理经验
· Good technical understanding of QC test methods and analytical equipment.
充分了解QC检验方法及分析仪器
· Languages: English fluent, written and spoken
语言能力： 流利的英语读、写、说能力
任职要求
无
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公司信息
广州市君信药业有限公司
- 上海
- 100-499人
- 生物制药、生物技术
- 外企
- 无
