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微生物检验员
10-15K/月北京市-北京/本科及以上/1-3年
薛先生一周前来过
北京科锐国际人力资源股份有限公司
职位详情
岗位职责
1. Carry out microbial limit test for raw material, excipient, primary packaging and clean utilities, intermediate, semi-product and final product as test plqnning.
负责依据检验计划对进厂的原辅料、包装材料、公司生产的工艺用水、中间产品、半成品、制剂成品进行微生物相关检验；
2. Carry out to issue SOP and record for raw material, excipient, primary packaging and clean utilities, intermediate, semi-product and final product as specification.
负责依据质量标准起草：原辅料、包装材料、公司生产的工艺用水、中间产品、半成品、制剂成品的检验操作规程和检验记录；
3. Carry out to issue new product test methods of Microbial limit, Endotoxin, Sterility and related validation.
负责对新产品的微生物限度、细菌内毒素、无菌的检验方法及验证方案起草；
4. Carry out to manage medium, strain, reagent and standard reference.
负责管理培养基、菌种与试剂、试液、标准品；
5. Carry to issue performance qualification protocol and report for microbiology lab equipment, perform related calibration and maintenance.
负责微生物实验室设备的性能确认及方案、报告起草，校验及维护；
6. Carry out related microbial limit test for supporting production and technical supporting validation.
负责协助生产/工程部门完成相关验证的微生物试验；
7. Carry out OOS investigation.
负责对微生物试验偏差展开调查；
8. Actively complete other tasks arranged by superiors, department and company
完成上级安排的其他相关工作并按要求提出工作报告。
9. Quality Department HSE Responsibilities:
质量部HSE职责：
➤ Responsible for following the company's HSE policy, and integrated all requires into daily job.
负责贯彻公司HSE的有关规定，把公司HSE制度的措施贯彻到每个具体环节。
➤ Incorporate HSE work into the work plan.
将HSE工作纳入工作计划中。
➤ Organize the implementation of HSE management target plan of this department, implement HSE rules and regulations, HSE operation procedures and HSE technical action plan.
组织实施本部门HSE管理目标计划，落实HSE规章制度、HSE操作规程和HSE技术措施计划。
➤ Regularly carry out to identify HSE potential hazards and develop action plan and finish on time.
定期开展本部门HSE隐患排查治理工作，制定整改计划并按时完成隐患整改。
➤ Responsible for departmental HSE education and assessment; Timely working out of employee opinions.负责部门级HSE教育与考核工作；及时处理员工提出的意见。
➤ Actively cooperate with HSE management to prevent accidents happens.
积极配合HSE管理工作，防止各类事故的发生。
➤ Regularly carry out +QDCI meetings at all levels considering HSE8 requirements. Feedback HSE issues in a timely and accurate manner, and actively implement rmdiations..
定期开展本部门各级+QDCI会议，结合HSE8要求，及时、正确填写和反馈各类HSE问题，并积极落实整改。
➤ Participate in the investigation for accidents, analyze the root causes of accidents from the quality management perspective, and related CAPA.
参加事故调查分析工作，从质量管理角度分析事故原因，提出事故防范措施。
➤ Responsible for design annual department PASS plan, and ensure implementation as planned.
负责制定年度部门PASS计划，并按进度组织实施。
10. Sanofi (Beijing) Pharmaceutical Co., Ltd. Energy Policy: "Quality as the top priority, through technical, behavioral, human consciousness, continuously reduce the rate of energy consumption in product value, benefit the users, and promote company development". Good awareness of energy conservation is required, participate in energy saving actions, and assist in the continuous development of the energy management system.
赛诺菲（北京）制药有限公司能源方针：“以药品质量为第一要务，通过技术手段，行为规范，人为意识，不断降低产品价值中的能耗比重，造福广大用户，促进企业发展”要求每位员工具有良好的节能意识，积极的节能行动，协助能源管理体系的持续开展
➤ Actively propose energy-saving projects
积极提出节能方案
➤ Support the development of energy-saving projects and give positive feedback
支持节能项目的制定，积极反馈意见
➤ Participate in and implement energy-saving projects
参与并实施节能项目
➤ Participate in internal audit of energy management system
参与能源管理体系的内部评审
负责依据检验计划对进厂的原辅料、包装材料、公司生产的工艺用水、中间产品、半成品、制剂成品进行微生物相关检验；
2. Carry out to issue SOP and record for raw material, excipient, primary packaging and clean utilities, intermediate, semi-product and final product as specification.
负责依据质量标准起草：原辅料、包装材料、公司生产的工艺用水、中间产品、半成品、制剂成品的检验操作规程和检验记录；
3. Carry out to issue new product test methods of Microbial limit, Endotoxin, Sterility and related validation.
负责对新产品的微生物限度、细菌内毒素、无菌的检验方法及验证方案起草；
4. Carry out to manage medium, strain, reagent and standard reference.
负责管理培养基、菌种与试剂、试液、标准品；
5. Carry to issue performance qualification protocol and report for microbiology lab equipment, perform related calibration and maintenance.
负责微生物实验室设备的性能确认及方案、报告起草，校验及维护；
6. Carry out related microbial limit test for supporting production and technical supporting validation.
负责协助生产/工程部门完成相关验证的微生物试验；
7. Carry out OOS investigation.
负责对微生物试验偏差展开调查；
8. Actively complete other tasks arranged by superiors, department and company
完成上级安排的其他相关工作并按要求提出工作报告。
9. Quality Department HSE Responsibilities:
质量部HSE职责：
➤ Responsible for following the company's HSE policy, and integrated all requires into daily job.
负责贯彻公司HSE的有关规定，把公司HSE制度的措施贯彻到每个具体环节。
➤ Incorporate HSE work into the work plan.
将HSE工作纳入工作计划中。
➤ Organize the implementation of HSE management target plan of this department, implement HSE rules and regulations, HSE operation procedures and HSE technical action plan.
组织实施本部门HSE管理目标计划，落实HSE规章制度、HSE操作规程和HSE技术措施计划。
➤ Regularly carry out to identify HSE potential hazards and develop action plan and finish on time.
定期开展本部门HSE隐患排查治理工作，制定整改计划并按时完成隐患整改。
➤ Responsible for departmental HSE education and assessment; Timely working out of employee opinions.负责部门级HSE教育与考核工作；及时处理员工提出的意见。
➤ Actively cooperate with HSE management to prevent accidents happens.
积极配合HSE管理工作，防止各类事故的发生。
➤ Regularly carry out +QDCI meetings at all levels considering HSE8 requirements. Feedback HSE issues in a timely and accurate manner, and actively implement rmdiations..
定期开展本部门各级+QDCI会议，结合HSE8要求，及时、正确填写和反馈各类HSE问题，并积极落实整改。
➤ Participate in the investigation for accidents, analyze the root causes of accidents from the quality management perspective, and related CAPA.
参加事故调查分析工作，从质量管理角度分析事故原因，提出事故防范措施。
➤ Responsible for design annual department PASS plan, and ensure implementation as planned.
负责制定年度部门PASS计划，并按进度组织实施。
10. Sanofi (Beijing) Pharmaceutical Co., Ltd. Energy Policy: "Quality as the top priority, through technical, behavioral, human consciousness, continuously reduce the rate of energy consumption in product value, benefit the users, and promote company development". Good awareness of energy conservation is required, participate in energy saving actions, and assist in the continuous development of the energy management system.
赛诺菲（北京）制药有限公司能源方针：“以药品质量为第一要务，通过技术手段，行为规范，人为意识，不断降低产品价值中的能耗比重，造福广大用户，促进企业发展”要求每位员工具有良好的节能意识，积极的节能行动，协助能源管理体系的持续开展
➤ Actively propose energy-saving projects
积极提出节能方案
➤ Support the development of energy-saving projects and give positive feedback
支持节能项目的制定，积极反馈意见
➤ Participate in and implement energy-saving projects
参与并实施节能项目
➤ Participate in internal audit of energy management system
参与能源管理体系的内部评审
任职要求
无
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公司信息
北京科锐国际人力资源股份有限公司
- 北京
- 1000-9999人
- 生物制药
- 民营
- 不需要融资
北京科锐国际人力资源股份有限公司是领先的以技术驱动的整体人才解决方案服务商，也是国内首家登陆A股的人力资源服务企业（300662.SZ），目前在中国、印度、新加坡、马来西亚、美国、英国、澳大利亚等全球市场拥有100+家分支机构，2,200余名专业招聘顾问，在超过18个行业及领域为客户提供中高端人才访寻、招聘流程外包、灵活用工、人力资源咨询、人才测评、人才培训与发展等人力资源全产业链服务。
