Together with colleagues in the region, the Regional QA Engineer, Integrated Solutions APAC, is part of the global QA team that is supporting the Custom Engineering and Integrated Solutions businesses world-wide. This person works as the QA representative for IS projects and project execution at customer sites, supports the effectiveness of the QMS, and liaises with stakeholders in the organization to drive continuous improvement.
This position reports to the QA Director – Custom Engineering & Integrated Solutions and is located in Singapore and will be an on-site role.
What you will do:
- Responsible for driving QA and compliance activities for the Integrated Solutions business in APAC, including but not limited to: Milestone approvals of projects, ensure resources for onsite QA support, act as onsite QA being the customer facing representative from QA
- Manage QMS processes like NC, CAPA, Complaints, document review and support internal/external audits
- Lead and manage validation QA strategy, project QA governance & processes, CIP (Continuous Improvement Project) & LL (Lesson Learnt Initiatives) for IS Business
- Support project performance reviews and develop input to Quality management reviews
- Supports development of training material and delivers training of quality associates and internal teams
Who you are:
- Essential Qualifications/Education: BEng or BSc
- Minimum 5 years of experience in Quality role, preferably in the Life Sciences industry
- Comprehensive understanding of ISO 9001 & cGMP requirements
- Experienced in managing project teams and working cross functionally, both locally & globally.
- Ability to communicate effectively in English plus one other language (for example: Chinese, Korean, Japanese) written and spoken.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
- Ability to travel globally and at short notice up to 50%
- Must have a valid driver’s license
It would be a plus if you also possess previous experience in:
- 5 to 10 years of proven experience as a quality assurance professional in a GMP environment
- Managing teams and direct reports across multiple locations
Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
