质量管理总监
太仓艾立特技术人才服务有限公司
- 公司规模：少于50人
- 公司性质：民营公司
- 公司行业：专业服务(咨询、人力资源、财会)
职位信息
- 发布日期：2012-11-13
- 工作地点：上海
- 招聘人数：1
- 工作经验：五年以上
- 学历要求：本科
- 语言要求：英语良好
普通话良好 - 职位类别：药品生产/质量管理 质量管理/测试经理(QA/QC经理)
职位描述
Qualifications:
1. Bachelor's degree or higher in Biology, chemistry, or life sciences
2. At least 5 years QA/QC work experiences in biopharmaceutical R&D setting, GLP working experiences will be a plus
3. Strong understanding of Quality System regulations and requirements and ability to assess and implement improvements tothe existing system.
4. Excellent organization, communication and teamwork skills and strong interpersonal skills to be able to effectively interact within multidisciplinary groups.
5. Ability to work effectively within cross-disciplinary teams and with vendors.
6. Creative problem solver and keen ability to address current and anticipated issues.
7. Strong leadership skills and demonstrated success in managing a large team.
8. Good speaking & writing skills in both English and Chinese capability.
Job Description:
1. Establish the Quality Assurance system to meet the requirement for CRO services business
2. Generate, revise, or approve SOPs and documents as necessary
3. Design, conduct and implement quality assurance audits to assure adherence to company SOP, and any applicable regulatory
4. Ensure a system operates effectively to manage change control, OOS's, complaints, CAPAs and deviations
5. Assess non-compliant findings and ensuring appropriate actions are agreed and effectively followed up - implementation and management of CAPA system.
6. Participate in hosting quality assurance inspections from existing or potential clients and regulatory agencies.
7. Lead quality input on contracts and be the primary contact for quality agreement negotiation.
8. Perform protocol, data, draft report audits and audits of final reports and inspects in-life phases and facilities as required for compliance with GLPs, SOPs, and/or government regulations
9. Report in writing to the Testing Facility Management and the Study Director all findings from the audits and inspections conducted
10. Maintain adequate staffing levels in the Quality Department; Identify need for additional personnel, interview, select and train qualified candidates.
11. Conduct performance appraisals for all salaried employees in the Quality Department.
1. Bachelor's degree or higher in Biology, chemistry, or life sciences
2. At least 5 years QA/QC work experiences in biopharmaceutical R&D setting, GLP working experiences will be a plus
3. Strong understanding of Quality System regulations and requirements and ability to assess and implement improvements tothe existing system.
4. Excellent organization, communication and teamwork skills and strong interpersonal skills to be able to effectively interact within multidisciplinary groups.
5. Ability to work effectively within cross-disciplinary teams and with vendors.
6. Creative problem solver and keen ability to address current and anticipated issues.
7. Strong leadership skills and demonstrated success in managing a large team.
8. Good speaking & writing skills in both English and Chinese capability.
Job Description:
1. Establish the Quality Assurance system to meet the requirement for CRO services business
2. Generate, revise, or approve SOPs and documents as necessary
3. Design, conduct and implement quality assurance audits to assure adherence to company SOP, and any applicable regulatory
4. Ensure a system operates effectively to manage change control, OOS's, complaints, CAPAs and deviations
5. Assess non-compliant findings and ensuring appropriate actions are agreed and effectively followed up - implementation and management of CAPA system.
6. Participate in hosting quality assurance inspections from existing or potential clients and regulatory agencies.
7. Lead quality input on contracts and be the primary contact for quality agreement negotiation.
8. Perform protocol, data, draft report audits and audits of final reports and inspects in-life phases and facilities as required for compliance with GLPs, SOPs, and/or government regulations
9. Report in writing to the Testing Facility Management and the Study Director all findings from the audits and inspections conducted
10. Maintain adequate staffing levels in the Quality Department; Identify need for additional personnel, interview, select and train qualified candidates.
11. Conduct performance appraisals for all salaried employees in the Quality Department.
公司介绍
太仓艾立特技术人才服务有限公司是由留德归国覃焱女士和一群有志报效祖国的海归所创办，吸纳了诸多留美加，留欧的留学归国人员加盟，海归占目前公司整个团队的30%。我们致力于为国际化企业及外资驻华机构提供量身定制的人力资源解决方案。我们为众多优秀的企业提供：国际化专业技术人才和高级管理人才寻访招聘服务，按照国际标准培训新兴产业高级技能人才和派遣服务，以及引进创新创业领军人才项目和项目配套人力资源整体服务.