QC Anayst / 质量控制分析员(理化分析)
浙江康泰伦特江元堂生物科技有限公司
- 公司规模：150-500人
- 公司性质：合资(非欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2017-05-26
- 工作地点：海宁
- 招聘人数：1人
- 工作经验：1年经验
- 学历要求：大专
- 语言要求：英语 良好
- 职位类别：质量检验员/测试员
职位描述
职位描述：
I. Essential Functions基本职责:
按照分析方法进行理化实验，确保符合质量、文件记录和GMP以及环境/安全/健康的要求。
To carry out Chemical analysis in compliance with analytical methods, ensuring quality, Good Documentation Practices, cGMP, safety health and environmental standards are met.
编写标准操作规程和分析检验方法并执行设备的验证和确认。
To write standard operating procedures, analytical methods to perform the equipment qualification and verification.
II. Specific Duties, Activities, and Responsibilities特殊职责，职能任务:
Responsibilities职责:
? 按照质量标准的要求进行原辅料、包装材料及成品的检验，做到测试的精确性和并按良好的文件记录规范进行记录。
Carry out chemical analysis of raw material, packaging material and finished products according to specification. Ensuring test accuracy and good documentation practice performed.
? 参与检验异常情况与偏差的调查并按时完成CAPA的整改。
Participate in the OOS and deviation investigations. Complete CAPA timely.
? 按计划对QC 实验室仪器进行维护、校准并准确记录和存档。
Implements the maintenance/validation/verification of laboratory equipment in compliance with the established schedules and maintain accurate records and documentation.
? 管理样品接收，及时取样，测试和放行，管理留样样品。
Manage incoming samples. Sampling and testing on time. Manage retention sample.
? 负责对照品的管理及记录。负责试剂、玻璃器皿、消耗品库存的管理及记录.
Maintain the standards as well as the relevant documentation and record. Maintain sufficient/adequate stock of regents，glassware，consumables etc. and their records.
? 编写质量标准、标准操作规程、仪器确认草案及分析方法验证方案。进行验证工作。
Draft specification, draft procedures, draft qualification protocols of the analytical instruments and the analytical methods. Perform the qualification work.
? 上级安排的其他工作。Other works assigned by the leader.
III. Position Requirements职位要求:
Education or Equivalent教育或同等学历: (Minimum required to perform job工作的最低要求)
? 大专以上学历，化工，食品或其他相关专业。
college degree or above in chemistry, food, or related.
? 食品，营养品，或者制药工厂实验室1年以上相关工作经验。
At least 1 years extensive experience in Food, Nutritional or Pharmaceutical manufacturing Lab is preferred.
Knowledge/Skills Requirements知识/技能要求:
? 熟悉各种分析仪器，如高效液相、气相、紫外、红外、原子吸收仪等的操作及维护Be familiar with analytical instrumental such as HPLC, GC, UV, IR, AAS operation and maintenance.
? 熟悉GLP/GMP，有ISO17025相关经验则更好。Familiar with GLP/GMP, if have experience of ISO17025 that is prefect.
? 良好的分析和解决问题的能力。
Good problem solving and analytical skills.
? 能够管理多重任务。
Must be capable of managing multiple tasks.
? 良好的英语技能。
Good English language skills.
? 计算机技能熟练（Excel, Word 和 PowerPoint）
Proficient computer skills (Excel, Word and PowerPoint).
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I. Essential Functions基本职责:
按照分析方法进行理化实验，确保符合质量、文件记录和GMP以及环境/安全/健康的要求。
To carry out Chemical analysis in compliance with analytical methods, ensuring quality, Good Documentation Practices, cGMP, safety health and environmental standards are met.
编写标准操作规程和分析检验方法并执行设备的验证和确认。
To write standard operating procedures, analytical methods to perform the equipment qualification and verification.
II. Specific Duties, Activities, and Responsibilities特殊职责，职能任务:
Responsibilities职责:
? 按照质量标准的要求进行原辅料、包装材料及成品的检验，做到测试的精确性和并按良好的文件记录规范进行记录。
Carry out chemical analysis of raw material, packaging material and finished products according to specification. Ensuring test accuracy and good documentation practice performed.
? 参与检验异常情况与偏差的调查并按时完成CAPA的整改。
Participate in the OOS and deviation investigations. Complete CAPA timely.
? 按计划对QC 实验室仪器进行维护、校准并准确记录和存档。
Implements the maintenance/validation/verification of laboratory equipment in compliance with the established schedules and maintain accurate records and documentation.
? 管理样品接收，及时取样，测试和放行，管理留样样品。
Manage incoming samples. Sampling and testing on time. Manage retention sample.
? 负责对照品的管理及记录。负责试剂、玻璃器皿、消耗品库存的管理及记录.
Maintain the standards as well as the relevant documentation and record. Maintain sufficient/adequate stock of regents，glassware，consumables etc. and their records.
? 编写质量标准、标准操作规程、仪器确认草案及分析方法验证方案。进行验证工作。
Draft specification, draft procedures, draft qualification protocols of the analytical instruments and the analytical methods. Perform the qualification work.
? 上级安排的其他工作。Other works assigned by the leader.
III. Position Requirements职位要求:
Education or Equivalent教育或同等学历: (Minimum required to perform job工作的最低要求)
? 大专以上学历，化工，食品或其他相关专业。
college degree or above in chemistry, food, or related.
? 食品，营养品，或者制药工厂实验室1年以上相关工作经验。
At least 1 years extensive experience in Food, Nutritional or Pharmaceutical manufacturing Lab is preferred.
Knowledge/Skills Requirements知识/技能要求:
? 熟悉各种分析仪器，如高效液相、气相、紫外、红外、原子吸收仪等的操作及维护Be familiar with analytical instrumental such as HPLC, GC, UV, IR, AAS operation and maintenance.
? 熟悉GLP/GMP，有ISO17025相关经验则更好。Familiar with GLP/GMP, if have experience of ISO17025 that is prefect.
? 良好的分析和解决问题的能力。
Good problem solving and analytical skills.
? 能够管理多重任务。
Must be capable of managing multiple tasks.
? 良好的英语技能。
Good English language skills.
? 计算机技能熟练（Excel, Word 和 PowerPoint）
Proficient computer skills (Excel, Word and PowerPoint).
职能类别： 质量检验员/测试员
公司介绍
Catalent Overview
Catalyst + Talent! Our name combines these ideas. As the world’s #1 drug development, delivery and supply partner with over 80 years of experience, we are the catalyst for your success. We have helped thousands of innovators by optimizing and manufacturing thousands of pharmaceutical, biologic, consumer health, beauty products and animal health utilizing our superior and innovative drug delivery technologies to improve their value to patients and consumers.
Catalent is a vibrant growing community of 8,500 global employees with the passion to unlock the potential of your product. From early development to clinical supply and commercial manufacturing, our 30+ global site teams support you through all phases of development, delivery, and supply, accelerating your product’s path to market in segments. Our legacy of drug development goes much deeper, incorporating the inventions and innovations which have transformed the pharmaceutical industry. On July 30, 2014 Catalent announced its initial public offering and became a publicly traded on the New York Stock Exchange under the ticker symbol CTLT.
Additionally, we have over 700 products in development at any time and partner with
• 87 of the top 100 pharmaceutical companies
• 24 of the top 25 biotechnology companies
• 22 of the top 25 generic drug companies
• 21 of the top 25 consumer health companies
Catalent. More products. Better treatments. Reliably supplied.™
For more information please visit our website www.catalent.com
康泰伦特概览
催化剂 + 人才！我们的名称结合于这两个概念。作为全球第一的药品研发、给药技术及供应的合作伙伴，我们已拥有80多年的经验，也是客户成功的催化剂。我们与成千上万家企业进行合作，运用全球最尖端领先的给药技术去协助客户优化及生产过几千种药品及生物制剂、健康消费品、美容产品和动物健康品，从而提升客户在患者与消费者心中的价值。
康泰伦特是一家朝气蓬勃的公司，在全球拥有8500名雇员为客户提供最专业的服务。我们在全球拥有30多家工厂，从临床研发初期到正式生产上市的每一个环节（研发、给药技术、供应），我们均可根据客户不同产品的市场定位和需求提供本领域最专业技术解决方案。我们专注于药品研发持续性的革新与创新，并且为整个制药行业的变革带来深远的意义。康泰伦特于2014年7月30日正式宣布首次在美国纽约证券交易所挂牌上市，股票代号：CTLT。
此外，我们拥有700多个产品随时在与客户进行研发合作：
• 全球前100强中的87家制药企业
• 全球前25强中的24家生物技术企业
• 全球前25家中的22家仿制药企业
• 全球前25家中的21家健康消费品企业
康泰伦特。更多的产品。更好的治疗。可靠地供应。™
获取更多信息请浏览公司官网 www.catalent.com
Catalyst + Talent! Our name combines these ideas. As the world’s #1 drug development, delivery and supply partner with over 80 years of experience, we are the catalyst for your success. We have helped thousands of innovators by optimizing and manufacturing thousands of pharmaceutical, biologic, consumer health, beauty products and animal health utilizing our superior and innovative drug delivery technologies to improve their value to patients and consumers.
Catalent is a vibrant growing community of 8,500 global employees with the passion to unlock the potential of your product. From early development to clinical supply and commercial manufacturing, our 30+ global site teams support you through all phases of development, delivery, and supply, accelerating your product’s path to market in segments. Our legacy of drug development goes much deeper, incorporating the inventions and innovations which have transformed the pharmaceutical industry. On July 30, 2014 Catalent announced its initial public offering and became a publicly traded on the New York Stock Exchange under the ticker symbol CTLT.
Additionally, we have over 700 products in development at any time and partner with
• 87 of the top 100 pharmaceutical companies
• 24 of the top 25 biotechnology companies
• 22 of the top 25 generic drug companies
• 21 of the top 25 consumer health companies
Catalent. More products. Better treatments. Reliably supplied.™
For more information please visit our website www.catalent.com
康泰伦特概览
催化剂 + 人才！我们的名称结合于这两个概念。作为全球第一的药品研发、给药技术及供应的合作伙伴，我们已拥有80多年的经验，也是客户成功的催化剂。我们与成千上万家企业进行合作，运用全球最尖端领先的给药技术去协助客户优化及生产过几千种药品及生物制剂、健康消费品、美容产品和动物健康品，从而提升客户在患者与消费者心中的价值。
康泰伦特是一家朝气蓬勃的公司，在全球拥有8500名雇员为客户提供最专业的服务。我们在全球拥有30多家工厂，从临床研发初期到正式生产上市的每一个环节（研发、给药技术、供应），我们均可根据客户不同产品的市场定位和需求提供本领域最专业技术解决方案。我们专注于药品研发持续性的革新与创新，并且为整个制药行业的变革带来深远的意义。康泰伦特于2014年7月30日正式宣布首次在美国纽约证券交易所挂牌上市，股票代号：CTLT。
此外，我们拥有700多个产品随时在与客户进行研发合作：
• 全球前100强中的87家制药企业
• 全球前25强中的24家生物技术企业
• 全球前25家中的22家仿制药企业
• 全球前25家中的21家健康消费品企业
康泰伦特。更多的产品。更好的治疗。可靠地供应。™
获取更多信息请浏览公司官网 www.catalent.com
联系方式
- Email：recruiter.china@catalent.com
- 公司地址：上班地址：长安镇