该职位来源于猎聘 JOB RESPONSIBILITIES Primary Responsibility

• Perform QMS audit to vendors, issue audit report, and CAPA follow-up
• Work as project leader in Vendor FDA project, supervise vendor to adequately establish and maintain QMS based on 21CFR820 or 21CFR210&211, and work with vendor to deal with FDA onsite audit
• Provide necessary QMS training to vendor
• Provide QMS support for new vendor set up project (Drug/cosmetic/lab)
• Work as a higher supporting role to ensure Lower level could get adequate supporting on below RA task assigned to FDA project team＜Cooperate with Medline Group-RA team, support as communication bridge and document reviewer, and ensure effectively document submission from vendor side for product license registration, internal & external audit and other requirements within required timeline.＞
• Perform GMP pre-audit to vendor for coming 3rd party/customer audit (Drug/cosmetic/lab), work with vendor to get approve of CAPA plan by 3rd party/customer. According to corporation business demand, work as consultant to help vendor readiness for 3rd party/customer GMP audit
• Coordinate and work closely with different levels of vendor and cross-function team to ensure audits and projects are completed on time and can meet the requirements
• Actively communicate with internal / external stakeholders to support audits and projects
• Provide technical support and share knowledge to team when needed; organize the team knowledge sharing and training activities
• Develops employees effectively through goal setting, performance management, IDP for team members; be aware of direct reports’ career goals through conversation; provide challenging tasks for team members; help direct reports to improve performance to Development themselves
• Work as a higher supporting role to ensure Lower level getting adequate supporting on fulfilling FDA project Team`s responsibility in Asia recall management process.
  
  

12, Work as a higher supporting role to ensure Lower level getting adequate supporting on fulfilling FDA project Team`s responsibility in assigned product listing and vendor registration affair.

• Work as a higher supporting role to ensure Lower level getting adequate supporting on fulfilling FDA project Team`s responsibility in Internal Pre-audit task.
  
  

Secondary Responsibility

• Other duties and projects as assigned.
• Drive Kaizen projects with team.
• Support QMS training to internal staff Qualification
• Bachelor’s Degree or above, major in science and engineering, in Medical science, pharmacy or Microbiology is a plus
• Minimum of 3 years` experience on Drug product QMS audit, or relevant fields.
• Minimum of 5 years` experience on Medical device product QMS audit, or relevant fields.
• Minimum of 5 years` experience in Medical device or drug/cosmetic relevant industry.
• Familiarity with MS office, Adobe Reader/Acrobat and other general office software.