職位概要(Job summary):
The Regulatory Compliance Sr. Engineer is to monitor and ensure the compliance to external standards/requirements and Quasar Quality System Requirements in Quasar manufacturing site.
工作職責(zé)(Responsibilities):
1. Conduct routine monitoring, checking program to identify site compliance gaps and follow up gap remediation.
2. Participate in Corporate Procedure Development & Maintenance. Join Corporate audit on other sites when required.
3. Provide Regulation Compliance supporting on critical business projects, when necessary, e.g., MAH
4. Facilitate critical external audits/inspection at site. e.g., FDA inspection, NMPA audits.
5. Join cross sites QMS IT system coordination and maintenance.
6. Responsible for liaising with the company’s internal/external stakeholders to identify/understand the required Regulatory Compliance knowledge needed to provide the required expertise and advice.
7. Other tasks assigned by leader.
任職資格(Qualification) :
1. Bachelor or Master’s degree in science related field.
2. Minimum of 5 years’ experiences on Medical Device or Pharmaceutical Industry Quality Regulatory Compliance related work. Knowledgeable on international standards or Health Authorities regulations requirement.
3. Good oral and written communication skills both in English and Chinese.
4. Good interpersonal and influential skills.
5. Ability to work under pressure in a dynamic environment.