IPQA/现场QA
山德士（中国）制药有限公司 Sandoz (China) Pharmaceutical Co., Ltd.
- 公司规模：500-1000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：2017-05-26
- 工作地点：中山
- 招聘人数：若干人
- 学历要求：大专
- 语言要求：英语 一般
- 职位月薪：3-4.5千/月
- 职位类别：药品生产/质量管理
职位描述
职位描述：
Job Purpose工作目的
In scope of quality assurance, responsible for compliance monitoring during production, participate in quality related issue investigation and evaluation , BPR first review. the environmental monitoring and water system monitoring.
在质量保证范围内，负责生产过程的合规监控、参与质量相关事件的调查和评估、批记录的初审、环境监控和水系统监控等。
Major Accountabilities主要职责
? Responsible for the check in line clearance of production, material status, reprocessing, and packaging stages and other critical steps or aspects which may influence the quality of products.
负责检查生产清场、物料状态、返工、包装和其他可能影响产品质量的步骤；
? Responsible for shop floor quality monitoring, sampling and relevant works, make sure all the products produced in Zhongshan site compliance with GMP.
负责现场质量监控、取样和相关工作，确保所有中山工厂生产的产品符合GMP要求；
? Responsible for the checking and qualifying of the equipment maintain, process and materials change.
负责检查和确认设备维修、工艺和物料的变更情况收集；
? Responsible for the environmental monitoring and water system monitoring.
负责环境监控和水系统监控；
? Responsible for checking on the disposal materials and monitor the destroying operation.
负责不合格物料的检查和监控销毁；
? Participate in any quality related issue investigation and evaluation.
参与质量相关事件的调查和评估；
? BPR collecting and first review.
批记录的收集整理和初审。
Key Performance Indicators 关键绩效指标
? On-site control: ensure the compliance of workshop,e.g..compliance of procees、consistence between operation and SOP
现场控制：确保车间现场的GMP符合性，如工艺的一致性，是否按SOP操作执行等。
? Environmental and PW system monitoring: perform environmental and PW system monitoring on schedule.
生产区环境和纯化水系统监控：按时完成生产区环境和纯化水系统的监控。
Background
背景
Education教育 : Graduate from pharmacy or relevant specialties above junior college. 必须是药学或相关专业大专以上的学历；
Languages语言: Mastering certain computer operating and professional English, and could finish task satisfactorily which refer to them.具有一定的电脑操作水平和专业英语水平，能很好的完成工作中涉及的这两方面的工作。
Experience经验:
Obtained proper training on pharmaceutical quality management, and with more than one year’s relevant working experience.有较好的药品质量管理培训和一年以上相关工作经验；
Familiar with items of GMP, can comply with requirements of GMP and relevant SOP strictly, and could judge and handle correctly common questions.熟悉GMP条款，并能严格的遵守GMP要求和执行相关的SOP，对药品生产和质量管理中的一般问题能够做出正确的判断和处理；
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Job Purpose工作目的
In scope of quality assurance, responsible for compliance monitoring during production, participate in quality related issue investigation and evaluation , BPR first review. the environmental monitoring and water system monitoring.
在质量保证范围内，负责生产过程的合规监控、参与质量相关事件的调查和评估、批记录的初审、环境监控和水系统监控等。
Major Accountabilities主要职责
? Responsible for the check in line clearance of production, material status, reprocessing, and packaging stages and other critical steps or aspects which may influence the quality of products.
负责检查生产清场、物料状态、返工、包装和其他可能影响产品质量的步骤；
? Responsible for shop floor quality monitoring, sampling and relevant works, make sure all the products produced in Zhongshan site compliance with GMP.
负责现场质量监控、取样和相关工作，确保所有中山工厂生产的产品符合GMP要求；
? Responsible for the checking and qualifying of the equipment maintain, process and materials change.
负责检查和确认设备维修、工艺和物料的变更情况收集；
? Responsible for the environmental monitoring and water system monitoring.
负责环境监控和水系统监控；
? Responsible for checking on the disposal materials and monitor the destroying operation.
负责不合格物料的检查和监控销毁；
? Participate in any quality related issue investigation and evaluation.
参与质量相关事件的调查和评估；
? BPR collecting and first review.
批记录的收集整理和初审。
Key Performance Indicators 关键绩效指标
? On-site control: ensure the compliance of workshop,e.g..compliance of procees、consistence between operation and SOP
现场控制：确保车间现场的GMP符合性，如工艺的一致性，是否按SOP操作执行等。
? Environmental and PW system monitoring: perform environmental and PW system monitoring on schedule.
生产区环境和纯化水系统监控：按时完成生产区环境和纯化水系统的监控。
Background
背景
Education教育 : Graduate from pharmacy or relevant specialties above junior college. 必须是药学或相关专业大专以上的学历；
Languages语言: Mastering certain computer operating and professional English, and could finish task satisfactorily which refer to them.具有一定的电脑操作水平和专业英语水平，能很好的完成工作中涉及的这两方面的工作。
Experience经验:
Obtained proper training on pharmaceutical quality management, and with more than one year’s relevant working experience.有较好的药品质量管理培训和一年以上相关工作经验；
Familiar with items of GMP, can comply with requirements of GMP and relevant SOP strictly, and could judge and handle correctly common questions.熟悉GMP条款，并能严格的遵守GMP要求和执行相关的SOP，对药品生产和质量管理中的一般问题能够做出正确的判断和处理；
职能类别： 药品生产/质量管理
公司介绍
山德士是瑞士诺华集团的子公司，诺华集团是世界第三大制药公司、世界500强企业，是全球唯一在专利药、非专利药、疫苗和非处方药业务上都拥有领导地位的制药公司。诺华集团成立于1996年，由瑞士两家具有百年历史的世界著名制药公司汽巴-嘉基与山德士合并而成。山德士主要从事非专利药品的研发、生产和销售，业务涵盖原料药、制剂和生物制品，拥有950多个化合物和5000多种制剂，是全球第二大非专利药公司。山德士（中国）2007年1月正式开展中国业务，于当年12月20日向德国格兰泰公司收购了位于中山市火炬区健康基地的中山格兰泰制药，并在中山成立了山德士(中国)制药有限公司，注册资金2200万美元，投资总额达3500万美元.
联系方式
- Email：referral.hr@sandoz.com
- 公司地址：地址：span北京