一线技术员(无锡工厂)
辉瑞制药有限公司
- 公司规模:5000-10000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2017-03-31
- 工作地点:无锡
- 招聘人数:若干人
- 职位月薪:4.5-6千/月
- 职位类别:质量管理/测试工程师(QA/QC工程师)
职位描述
职位描述:
工作职责:
1.生产运行Production operation
根据相关SOP及批生产记录的要求完成无菌生产工作。根据数据完整性要求填写日志及批记录。为了满足市场对产品产量和质量的需求,充分利用各种资源,协调并参与无菌生产使之有序进行.
Conduct aseptic production operation according to the relative SOP and batch record.
Record the logbook and batch record according to the data integrity requirement.
Meet the market need , make full use of various resources, coordinate and participate in aseptic production and make sure production go smoothly.
2.参与批记录的审核,SAP中物料的领料、退料;SOP的修改及起草
Take part in batch record review. Material receiving and return in SAP system. Responsible for revise and issue SOP.
3.产品质量控制Product quality control
确保生产过程中各环节符合国家GMP要求,公司总部PQS要求,操作按标准、操作程序执行,使产品质量得到有效保证
Ensure production process meet the CGMP requirements, PQS requirements. Operate according to the standards, operation procedure, so that the product quality is effectively guaranteed.
4.设备维护与管理Equipment maintenance and management
参与日常的设备使用、清洁、维护,使设备处于有效运行与管理之中。
Clean and maintain the equipment in the daily operation.
5.安全与卫生Safety and health
具有安全和卫生相关知识,保证生产的安全进行,保证生产现场清洁卫生,符合国家及公司要求,遵守相应的管理措施。
Have safety and health knowledge to ensure the safety of production, the staff should ensure the production site clean, conform to the requirements and comply with the relevant management measures.
6.新产品、新设备与新工艺New products, new equipment and new technology
参与并协助管理团队进行新产品试制和新设备的调试,
Participate in and cooperate with management team to finish new product development and new equipment debugging.
7.团队精神Team spirit
为了完成团队共同目标,团结团队中其它员工,达成共同目标。
Build up an effective team to accomplish team’s targets.
8.人员培训及发展 Personnel training and development
协助管理人员制定培训规程及计划,并通过合适的程序保证员工得到有效的培训. Cooperate with management team prepare training procedures and plan to ensure that the staff s get appropriate training before taking the job.
9.改进生产工艺,提高效率Improve production process and efficiency
提高生产效率、发挥生产能力、稳定产品质量,对工艺、设备、流程等进行不断的改进与完善,满足不断的发展需求
Iimprove the production efficiency, production capacity, stability of product quality, he should improve and perfect the technology, equipment, process and so on and meet the developing needs.
10.遵守公司有关EHS的政策和规定,并负责生产部EHS相关工作
Comply with company policies and regulations related to EHS, and responsible for department EHS work.
11.配合验证及新验证项目的实施。
Cooperate to conduct annual re-validation and new project’s validation work.
任职资格:
教育程度经验Education Background Experience
本科以上学历,制药化工相关专业,具有相关工作经验的人员优先。
Bachelor degree or above, major in pharmaceutical or chemical engineering, at least two years of relevant working experience.
特别知识Special Knowledge
制药专业知识, GMP专门知识,验证知识,其它国家药品法规,劳动法、环保法等。
Pharmaceutical expertise, GMP expertise, validation knowledge, other national drug laws, labor law, environmental law, etc..
技能Skills:
良好的沟通能力和团队精神及分析判断能力;
Good communication skills and team spirit and ability to analyze and judge;
良好的英语综合能力,熟练使用计算机并会操作OFFICE办公软件;
Good English comprehensive ability and good at using computer and can operate OFFICE software;
具有不断学习接受新知识的能力;
Ability to continuously learn and accept new knowledge;
具有同时进行并完成多种任务的能力。
Ability to perform multiple tasks at the same time.
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工作职责:
1.生产运行Production operation
根据相关SOP及批生产记录的要求完成无菌生产工作。根据数据完整性要求填写日志及批记录。为了满足市场对产品产量和质量的需求,充分利用各种资源,协调并参与无菌生产使之有序进行.
Conduct aseptic production operation according to the relative SOP and batch record.
Record the logbook and batch record according to the data integrity requirement.
Meet the market need , make full use of various resources, coordinate and participate in aseptic production and make sure production go smoothly.
2.参与批记录的审核,SAP中物料的领料、退料;SOP的修改及起草
Take part in batch record review. Material receiving and return in SAP system. Responsible for revise and issue SOP.
3.产品质量控制Product quality control
确保生产过程中各环节符合国家GMP要求,公司总部PQS要求,操作按标准、操作程序执行,使产品质量得到有效保证
Ensure production process meet the CGMP requirements, PQS requirements. Operate according to the standards, operation procedure, so that the product quality is effectively guaranteed.
4.设备维护与管理Equipment maintenance and management
参与日常的设备使用、清洁、维护,使设备处于有效运行与管理之中。
Clean and maintain the equipment in the daily operation.
5.安全与卫生Safety and health
具有安全和卫生相关知识,保证生产的安全进行,保证生产现场清洁卫生,符合国家及公司要求,遵守相应的管理措施。
Have safety and health knowledge to ensure the safety of production, the staff should ensure the production site clean, conform to the requirements and comply with the relevant management measures.
6.新产品、新设备与新工艺New products, new equipment and new technology
参与并协助管理团队进行新产品试制和新设备的调试,
Participate in and cooperate with management team to finish new product development and new equipment debugging.
7.团队精神Team spirit
为了完成团队共同目标,团结团队中其它员工,达成共同目标。
Build up an effective team to accomplish team’s targets.
8.人员培训及发展 Personnel training and development
协助管理人员制定培训规程及计划,并通过合适的程序保证员工得到有效的培训. Cooperate with management team prepare training procedures and plan to ensure that the staff s get appropriate training before taking the job.
9.改进生产工艺,提高效率Improve production process and efficiency
提高生产效率、发挥生产能力、稳定产品质量,对工艺、设备、流程等进行不断的改进与完善,满足不断的发展需求
Iimprove the production efficiency, production capacity, stability of product quality, he should improve and perfect the technology, equipment, process and so on and meet the developing needs.
10.遵守公司有关EHS的政策和规定,并负责生产部EHS相关工作
Comply with company policies and regulations related to EHS, and responsible for department EHS work.
11.配合验证及新验证项目的实施。
Cooperate to conduct annual re-validation and new project’s validation work.
任职资格:
教育程度经验Education Background Experience
本科以上学历,制药化工相关专业,具有相关工作经验的人员优先。
Bachelor degree or above, major in pharmaceutical or chemical engineering, at least two years of relevant working experience.
特别知识Special Knowledge
制药专业知识, GMP专门知识,验证知识,其它国家药品法规,劳动法、环保法等。
Pharmaceutical expertise, GMP expertise, validation knowledge, other national drug laws, labor law, environmental law, etc..
技能Skills:
良好的沟通能力和团队精神及分析判断能力;
Good communication skills and team spirit and ability to analyze and judge;
良好的英语综合能力,熟练使用计算机并会操作OFFICE办公软件;
Good English comprehensive ability and good at using computer and can operate OFFICE software;
具有不断学习接受新知识的能力;
Ability to continuously learn and accept new knowledge;
具有同时进行并完成多种任务的能力。
Ability to perform multiple tasks at the same time.
职能类别: 质量管理/测试工程师(QA/QC工程师)
公司介绍
辉瑞公司(Pfizer Inc.)创建于1849年,迄今已有160多年的历史,总部位于美国纽约,是目前全球***的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元,研发投入78亿美元。辉瑞在全球拥有9万多名员工,59家生产基地,业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域,同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中,辉瑞始终致力于奉行严格的质量、安全和价值标准。每天,分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作,支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来,辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个,其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗,辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓,并以其优异的品质深受广大消费者的青睐;辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元,研发投入78亿美元。辉瑞在全球拥有9万多名员工,59家生产基地,业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域,同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中,辉瑞始终致力于奉行严格的质量、安全和价值标准。每天,分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作,支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来,辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个,其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗,辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓,并以其优异的品质深受广大消费者的青睐;辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.
联系方式
- Email:chinahrwest@Pfizer.com
- 公司地址:南京西路中信泰富