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QA Specialist – CCR

Job Responsibilities

  • Assist QA Manager with managing Change Control systems. 
  • Review Change Control documents. 
  • Generate and revise of SOPs. 
  • Participate in the internal/external auditing program for JHL Taiwan as required. 
  • Monitor and evaluate adequacy of Change Control Actions, 
  • completeness of reports. 
  • Responsible for Change Control systems to ensure the activities carried out on this site could meet regulatory requirement. 
  • Assist QA Manager ensuring on time correspondences and updating customers and/or regulators on the status of corrective actions 
  • Responsible to verify the effectiveness of corrective/preventive actions

Job Qualifications (Education, Certifications, Experience)

  • BS/MS degree, scientific discipline preferred. 
  • 2-5 years’ experience in a Quality regulated industry, pharmaceutical or medical device experience is preferred. 
  • Proficiency in the use of Microsoft Office Applications and Adobe Acrobat Professional. 
  • Experience with Change Control System is a plus. 
  • Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.
  • In-depth knowledge of GMPs and related guidelines and regulatory requirements. 
  • Prior work experience and knowledge of FDA regulated manufacturing work environment a plus 
  • Good oral and written communication skills in English and Mandarin (Read, Write, Verbal) demonstrated by communicating effectively with other functions and management processes within Quality Assurance and multi-disciplinary teams. 
  • Flexible to changing demands, timelines and deliverables.