Integrate and support quality regulations, including Japan Pharmaceutical Affairs Law and GQP/QMS ordinance. Design and implement quality systems, procedures, and processes with cross-functional teams. Analyze quality indicators and performance metrics, and communicate compliance status and risks. Lead project teams in planning, reviewing, and approving quality documentation. Assess and improve compliance to processes, procedures, and regulations; support quality inspections and audits. Manage supplier qualification programs and monitor supplier performance. Investigate quality events and develop action plans for deviations and product complaints. Represent affiliate QA in regional, global, and cross-functional teams, and support technology transfer for new or changed products in Japan.
業務内容:
Integrate and support quality regulations, including Japan Pharmaceutical Affairs Law and GQP/QMS ordinance
Design and implement quality systems, procedures, and processes with cross-functional teams
Analyze quality indicators and performance metrics, and communicate compliance status and risks
Lead project teams in planning, reviewing, and approving quality documentation
Assess and improve compliance to processes, procedures, and regulations
support quality inspections and audits
Manage supplier qualification programs and monitor supplier performance
Investigate quality events and develop action plans for deviations and product complaints
Represent affiliate QA in regional, global, and cross-functional teams, and support technology transfer for new or changed products in Japan
応募資格:
Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred
5+ years’ experience in quality assurance, quality oversight or relevant experience
Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations
Knowledge and familiarity with product, process, and both internal and external customer requirements
Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred
Experience working independently
Strong oral and written communication skills needed
Proficiency in English
Excellent interpersonal skills
Strong computer skills and knowledge of enterprise systems such as TrackWise
