QA Manager for Reagents and Instruments
珀金埃尔默仪器（上海）有限公司
- 公司规模：150-500人
- 公司性质：外资(欧美)
- 公司行业：医疗设备/器械 制药/生物工程
职位信息
- 发布日期：2013-04-22
- 工作地点：太仓
- 招聘人数：1
- 工作经验：五年以上
- 学历要求：本科
- 语言要求：英语熟练
- 职位类别：质量管理/测试经理(QA/QC经理)
职位描述
DUTIES AND RESPONSIBILITIES:
1. Ensure that the Quality System Procedures are in place and that compliance with relevant regulations is maintained through training and audit;
2. Provide leadership, direction and support to the people within the Quality Assurance department and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner;
3. Lead internal auidt activities for the quality system and follow up post actions;
4. Manage complaints, nonconformities and quality problems according to relevant procedures and organize CAPA meeting to solve these problems;
5 Coordinate and share a best practice and harmonization with other departments to ensure quality requirements understood and implemented within whole company;
6. Coordinate contact with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, distributors) and Global Quality Operations.
JOB REQUIREMENTS AND QUALIFICATION:
1. At least bachelor degree majoring in Biology/Chemical / Pharm./ Engineering or related;
2. Fluent in Oral and written English;
3. More than 5 work experience in IVD, Medical Device, biological Assay or Pharmaceutical industry;
4. Familiar to and experienced in ISO13485, ISO9001, GMP implementation and maintenance;
5. High degree of personal integrity and communication skill with Customers as well as the internal staff.
1. Ensure that the Quality System Procedures are in place and that compliance with relevant regulations is maintained through training and audit;
2. Provide leadership, direction and support to the people within the Quality Assurance department and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner;
3. Lead internal auidt activities for the quality system and follow up post actions;
4. Manage complaints, nonconformities and quality problems according to relevant procedures and organize CAPA meeting to solve these problems;
5 Coordinate and share a best practice and harmonization with other departments to ensure quality requirements understood and implemented within whole company;
6. Coordinate contact with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, distributors) and Global Quality Operations.
JOB REQUIREMENTS AND QUALIFICATION:
1. At least bachelor degree majoring in Biology/Chemical / Pharm./ Engineering or related;
2. Fluent in Oral and written English;
3. More than 5 work experience in IVD, Medical Device, biological Assay or Pharmaceutical industry;
4. Familiar to and experienced in ISO13485, ISO9001, GMP implementation and maintenance;
5. High degree of personal integrity and communication skill with Customers as well as the internal staff.
公司介绍
PerkinElmer Instruments (Shanghai) Co.,Ltd ( US company)
PerkinElmer is a global scientific leader providing an extensive range of technology solutions and services to address the most critical issues facing humanity. From critical research and prenatal screening to environmental testing and industrial monitoring, we’re actively engaged in improving health and enhancing quality of life all around the world.
PerkinElmer’s proud history dates back to the 1930s.Our legacy of scientific advancement, operational excellence and continual expansion, from Boston to Beijing, is the foundation of our mission to improve human and environmental health.
Collaborating with customers to identify risks, discover and monitor the things that matter most—from safer drinking water to cleaner air, faster research to healthier babies—is imperative to executing our mission.
Encouraging ingenuity and exploration; integrity and generosity; and, teamwork and employee development is essential to living our mission, every day.
PerkinElmer is a global scientific leader providing an extensive range of technology solutions and services to address the most critical issues facing humanity. From critical research and prenatal screening to environmental testing and industrial monitoring, we’re actively engaged in improving health and enhancing quality of life all around the world.
PerkinElmer’s proud history dates back to the 1930s.Our legacy of scientific advancement, operational excellence and continual expansion, from Boston to Beijing, is the foundation of our mission to improve human and environmental health.
Collaborating with customers to identify risks, discover and monitor the things that matter most—from safer drinking water to cleaner air, faster research to healthier babies—is imperative to executing our mission.
Encouraging ingenuity and exploration; integrity and generosity; and, teamwork and employee development is essential to living our mission, every day.
联系方式
- 联系人：HR