质量部验证工程师 (职位编号：46695526)
天津百特医疗用品有限公司
- 公司规模：500-1000人
- 公司性质：外资(欧美)
- 公司行业：医疗设备/器械
职位信息
- 发布日期：2021-01-11
- 工作地点：天津-北辰区
- 招聘人数：1人
- 工作经验：3-4年经验
- 学历要求：本科
- 职位类别：药品生产/质量管理
职位描述
Responsibility
The position is responsible for collaborating with production to ensure the process in compliance with Baxter standards, carrying out in process control according to Baxter standard procedure and implementing AQL sampling for release finished products.
- Perform on site inspection for inner bag/frangible/assembly and drug products manufacturing process based on GMP/ISO/SOPs.
- Coordinate to handle any exception in process timely in order to eliminate negative impact to finished goods quality.
- Draft QE SOPs, production SOP comment and finish related quality documents.
- Ensure processes are complied with SOPs and ensure in-process control and final functional test are inspected on time.
- Collect and analyze statistic data for manufacturing process.
- Implement or support process or projects validation.
- Support in process/product improvement, to ensure each improvement to be validated.
- Establish and maintain internal critical system, review and follow up any nonconformance or observation in internal and external quality audit.
- Cascading Corporate Quality Manual/Policy and ensure appropriate SOPs and Forms.
- Initiate ICAR/SCAR due to supplier quality issues.
- Assist to investigate customer complaint.
- Provide QE Support for drug production, such as procedure set up, in-process testing instrument purchasing and validation, training, validation supporting to production team and engineering team.
- Monitor and manage the warehouse based on GMP/ISO/SOPs.
- Obtain appropriate EHS training and report any incidents of noncompliance with EHS policy and requirements.
- Other tasks authorized by Quality supervisor.
Requirements
- At least a bachelor degree in pharmaceutical, medical or chemical.
- At least 2 years of working experience in quality control and quality assurance.
- Good judgment and independent on quality control process.
- Be able to read and understand English documents.
- Good human relationship skills
The position is responsible for collaborating with production to ensure the process in compliance with Baxter standards, carrying out in process control according to Baxter standard procedure and implementing AQL sampling for release finished products.
- Perform on site inspection for inner bag/frangible/assembly and drug products manufacturing process based on GMP/ISO/SOPs.
- Coordinate to handle any exception in process timely in order to eliminate negative impact to finished goods quality.
- Draft QE SOPs, production SOP comment and finish related quality documents.
- Ensure processes are complied with SOPs and ensure in-process control and final functional test are inspected on time.
- Collect and analyze statistic data for manufacturing process.
- Implement or support process or projects validation.
- Support in process/product improvement, to ensure each improvement to be validated.
- Establish and maintain internal critical system, review and follow up any nonconformance or observation in internal and external quality audit.
- Cascading Corporate Quality Manual/Policy and ensure appropriate SOPs and Forms.
- Initiate ICAR/SCAR due to supplier quality issues.
- Assist to investigate customer complaint.
- Provide QE Support for drug production, such as procedure set up, in-process testing instrument purchasing and validation, training, validation supporting to production team and engineering team.
- Monitor and manage the warehouse based on GMP/ISO/SOPs.
- Obtain appropriate EHS training and report any incidents of noncompliance with EHS policy and requirements.
- Other tasks authorized by Quality supervisor.
Requirements
- At least a bachelor degree in pharmaceutical, medical or chemical.
- At least 2 years of working experience in quality control and quality assurance.
- Good judgment and independent on quality control process.
- Be able to read and understand English documents.
- Good human relationship skills
职能类别：药品生产/质量管理
公司介绍
百特是全球领先的医疗用品公司，百特专注于危重治疗领域，在肾科、药物输注和生物科技等领域通过提供先进的多样化的产品和服务。
百特总部设在美国芝加哥，是***进入中国医疗市场的大型跨国公司之一，目前已在中国多个城市建立了办事处，并建立了五家大规模的合资和独资生产企业，一家研发中心。
天津百特医疗用品有限公司于1995年成立，占地面积10,496平米，其中实验室2,400平方米，500余名员工。目前主要产品是以葡萄糖、氯化钠为代表的大输液产品。
未来两年内，百特天津工厂将投产肾科相关腹膜透析产品，目前正在进行项目建设中，诚邀各方英才的加入！
百特总部设在美国芝加哥，是***进入中国医疗市场的大型跨国公司之一，目前已在中国多个城市建立了办事处，并建立了五家大规模的合资和独资生产企业，一家研发中心。
天津百特医疗用品有限公司于1995年成立，占地面积10,496平米，其中实验室2,400平方米，500余名员工。目前主要产品是以葡萄糖、氯化钠为代表的大输液产品。
未来两年内，百特天津工厂将投产肾科相关腹膜透析产品，目前正在进行项目建设中，诚邀各方英才的加入！
联系方式
- Email：TTA@baxter.com
- 公司地址：百特天津工厂