广州 [切换城市] 广州招聘广州质量管理/安全防护招聘广州质量管理/测试工程师(QA/QC工程师)招聘

QA Audit Specialist (质量审计专员)

龙沙生物技术有限公司

  • 公司规模:150-500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:2020-10-14
  • 工作地点:广州-黄埔区
  • 招聘人数:1人
  • 工作经验:3-4年经验
  • 学历要求:本科
  • 语言要求:英语良好
  • 职位月薪:0.8-1万/月
  • 职位类别:药品生产/质量管理  质量管理/测试工程师(QA/QC工程师)

职位描述


Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

    

    


Lonza is establishing a strategic biomanufacturing base in China using GE Healthcare Solutions. With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market. You need to Participate in the establishment and maintenance a robustness and cGMP compliance Quality Audit Systems.

    

    


Key responsibilities:

  • Implement and maintain Internal Audit Program
  • Follow up external regulatory inspections, Customers’ Quality Compliance audits
  • Follow up Lonza Global Quality assessments of Quality Management Systems
  • Able to direct appropriate follow-up actions on any compliance issues.
  • Excellent knowledge and adherence to all relevant codes, standards and regulatory requirements
  • Able to develop skill as an internal Good Manufacture Practices auditor.
  • Perform the gap analysis between Quality Management Systems & regulatory requirements
  • Ensure that documentation hand over and archiving is completed in accordance with department and company requirements.
  • Identify situation which may require escalation to supervisor;
  • Any other tasks as and when assigned by manager/ supervisor.

                                                


Key requirements:

  • Relevant experience and accomplishment to dictate final position for which the candidate may qualify
  • Good problem solving and analytical skills
  • Good communication skills
  • Decision Making
  • Planning/Organizing
  • Effective Communication
  • Personal Orientation
  • Teamwork

                                    

    


People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.


公司介绍

Lonza龙沙是全球医药、生命科学及营养保健领域的领先供应商之一。龙沙制药与生物技术业务提供全球化合同定制开发与生产(CDMO)服务,使制药与生物技术公司能为患者带来医学创新。龙沙以高信任度、高质量、全球产能、创新技术平台以及广泛的经验而备受认可。龙沙经营的项目涵盖从前期临床开发到商业化生产的全部过程,涉及哺乳动物和微生物的生物制品、小分子、生物偶联物、细胞和基因疗法等领域。

龙沙位于广州的生物技术生产基地将投入运营,提供临床前到早期商业化的开发和生产服务,以应对国内不断增长的高质量定制的需求。

联系方式

  • 公司地址:地址:span中新知识城