【应届生】成品药生产专员
喜康(武汉)生物医药有限公司WuhanUpdate time: May 17,2019
Job Description
岗位职责
Principal Duties and Responsibilities
1.参加成品药生产部门的日常活动。
Participate the daily activities of the Drug Product Manufacturing Group.
2.编制成品药生产流程文件。
Author documents for drug product manufacturing processes.
3.按要求参加内部审核程序。
Participate in the internal auditing program as required.
4.为QA提供有关GMP设施问题的意见，并对环境监测和验证计划进行监督。
Provide input to QA on GMP facility issues and maintain oversight of the Environmental Monitoring and Validation programs.
5.预测潜在问题并采取预防措施，并根据需要升级流程问题以确保解决问题。
Anticipate potential problems and take preventative actions and escalate process issues as necessary to ensure resolution.
6.审核文档并检查所有计算（例如批记录、标签设备读数）。
Review documentation and check all calculations (eg batch records, labels equipment readings).
7.确保操作严格遵守所有QA控制文件（例如SOP、批记录）和cGMP/质量要求。
Ensure operations strictly adhere to all QA-Controlled documents (such as SOPs, Batch Records) and cGMP/Quality requirements.
8.必要时升级流程问题以确保解决问题。
Escalate process issues as necessary to ensure resolution.
9.确保GMP培训要求完整且最新。
Ensure GMP training requirements are complete and current.
10.确保所有工作都以安全的方式执行，并符合各项服务需求规范。
Ensure all work is performed in a safe manner and meets the specifications for each service request.
11.在工厂的所有工作中使用适当的PPE（个人防护设备）。
Apply proper PPE (Personal Protective Equipment) to all work in the facility.
12.清洁并维护GMP设施和生产设备。
Clean and maintain the GMP facility and production equipment.
职位要求
Job Requirements
1.理科硕士学位（生物或工程学科，例如生物技术、生物化学、化学/生物化学工程等）。
M.S. degree; the degree should be in a biological or engineering discipline (Biotechnology, Biochemistry, Chemical/Biochemical Engineering, or equivalent).
2.具备对无菌生产工艺的技术理解，以及GMP生产、监管原则和要求等工作知识。
Technical understanding with aseptic manufacturing process and working knowledge of GMP manufacturing and regulatory principles and requirements.
3.具备无菌成品药生产经验，具备蛋白质药品生产经验者优先考虑。
Experienced in aseptic drug product manufacturing, preferably protein drug.
4.良好的中英文口头和书面交流能力（阅读、写作、口语）。
Good oral and written communication skills in English and Mandarin (Read, Write, Verbal).
5.能够编写详细的报告和总结，掌握良好的文档处理技术。
Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills.
6.能够在团队中进行有效沟通和专业工作。
Communicate effectively and work professionally in a team environment.
7.熟练使用计算机和自动化驱动设备。
Skilled in the use of computers and automation-drive equipment.
8.必须适应灵活的工作班次（白班、夜班、周末），接受加班。
Must be flexible to work on any shift (day, night, weekend) and able to work prolong duration on your feet.
Principal Duties and Responsibilities
1.参加成品药生产部门的日常活动。
Participate the daily activities of the Drug Product Manufacturing Group.
2.编制成品药生产流程文件。
Author documents for drug product manufacturing processes.
3.按要求参加内部审核程序。
Participate in the internal auditing program as required.
4.为QA提供有关GMP设施问题的意见，并对环境监测和验证计划进行监督。
Provide input to QA on GMP facility issues and maintain oversight of the Environmental Monitoring and Validation programs.
5.预测潜在问题并采取预防措施，并根据需要升级流程问题以确保解决问题。
Anticipate potential problems and take preventative actions and escalate process issues as necessary to ensure resolution.
6.审核文档并检查所有计算（例如批记录、标签设备读数）。
Review documentation and check all calculations (eg batch records, labels equipment readings).
7.确保操作严格遵守所有QA控制文件（例如SOP、批记录）和cGMP/质量要求。
Ensure operations strictly adhere to all QA-Controlled documents (such as SOPs, Batch Records) and cGMP/Quality requirements.
8.必要时升级流程问题以确保解决问题。
Escalate process issues as necessary to ensure resolution.
9.确保GMP培训要求完整且最新。
Ensure GMP training requirements are complete and current.
10.确保所有工作都以安全的方式执行，并符合各项服务需求规范。
Ensure all work is performed in a safe manner and meets the specifications for each service request.
11.在工厂的所有工作中使用适当的PPE（个人防护设备）。
Apply proper PPE (Personal Protective Equipment) to all work in the facility.
12.清洁并维护GMP设施和生产设备。
Clean and maintain the GMP facility and production equipment.
职位要求
Job Requirements
1.理科硕士学位（生物或工程学科，例如生物技术、生物化学、化学/生物化学工程等）。
M.S. degree; the degree should be in a biological or engineering discipline (Biotechnology, Biochemistry, Chemical/Biochemical Engineering, or equivalent).
2.具备对无菌生产工艺的技术理解，以及GMP生产、监管原则和要求等工作知识。
Technical understanding with aseptic manufacturing process and working knowledge of GMP manufacturing and regulatory principles and requirements.
3.具备无菌成品药生产经验，具备蛋白质药品生产经验者优先考虑。
Experienced in aseptic drug product manufacturing, preferably protein drug.
4.良好的中英文口头和书面交流能力（阅读、写作、口语）。
Good oral and written communication skills in English and Mandarin (Read, Write, Verbal).
5.能够编写详细的报告和总结，掌握良好的文档处理技术。
Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills.
6.能够在团队中进行有效沟通和专业工作。
Communicate effectively and work professionally in a team environment.
7.熟练使用计算机和自动化驱动设备。
Skilled in the use of computers and automation-drive equipment.
8.必须适应灵活的工作班次（白班、夜班、周末），接受加班。
Must be flexible to work on any shift (day, night, weekend) and able to work prolong duration on your feet.
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