Job Summary:
The position is to lead dose setting and dose mapping, perform manufacturer/sterilizer audit or vigilance in radiation program for Asia product families.


Job Responsibilities:
- Work as project leader and perform validations related to sterility assurance of irradiation products from vendors in Asia.
- Manage conflicts, interact with vendors and stakeholders, and communicate with internal team and cross-functional teams to push project development.
- Perform evaluation in irradiation product adoption, establish or update quality agreement, and radiation sterilization processing agreement.
- Complete audit/ vigilance to manufacturer or sterilizer, track the correction actions provided by manufacturer or sterilizer.
- Be able to issue SCAR, DV/ NC and SIR within work scope based on procedure independently when OOS happens.
- Review and update procedure within work scope.
- Provide technical support for team member, support on team knowledge sharing and training activities including new hires development.
- Support on sample irradiation in max dose evaluation according to request from division QA.
- Other work assigned by line manager.


Qualifications:
- Education level: Bachelor’s degree or above with science or engineering background. Microbiological background is a plus.
- Work experience: 3-5 years’ work experience in manufacturing or quality area or validation related job.
- Working Experience in medical device, pharmaceutical is an advantage.
- Specific knowledge: Biological and chemical background is preferred.
- Certifications: ISO11137, ISO11607, ISO13485, CFR820 is preferred.
- Language: Fluent at both verbal and written English.
- Good teamwork spirit and problem solving skills.
- Willing to travel with rate 30%.
- Good multiple project management skills.
- Good communication and training skills.
- Proficiency of PC skills: MS Office Software.