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QA Specialist – CAPA/Deviation

Job Responsibilities

  • Assist QA Manager in managing deviation, investigation and CAPA systems. 
  • Perform QA investigation team upon critical deviations as lead investigation. 
  • Responsible for issue deviations and Corrective and Preventive Actions (CAPA); lead cross functional team to perform root cause analysis and identify corrective actions. 
  • Responsible for verify the effectiveness of corrective/preventive actions 
  • Responsible for Quality Systems to ensure the activities carried out on this site could meet regulatory requirement. 
  • Monitor risk management activities 
  • Generate and revise of SOPs. 
  • Participate in the internal/external auditing program for JHL Taiwan as required. 
  • Execute internal audits and monitor quality related operations for continuous quality improvement within the organization 
  • Participate in the execution of the Product Complaint system and assist with product return, withdrawal or recall activities, as needed. 

Job Qualifications (Education, Certifications, Experience)

  • BS/MS degree, scientific discpline preferred. 
  • 2-5 years experience in a Quality regulated industry, pharmaceutical or medical device experience is preferred. 
  • Experience with GMP Quality Systems is required. 
  • In-depth knowledge of GMPs and related guidelines and regulatory requirements. 
  • Proficiency in the use of Microsft Office Applications and Adobe Acrobat Professional. 
  • Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines. 
  • 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. 
  • Adaptable and flexible to adjust to changing demands, timelines, deliverables