Regulatory Compliance

仕事内容

Job Description:

·Coordination and Response to Inspections by Authorities and Clients.

· Internal Audit Management and CAPA Tracking.

· CMOs/Contract Labs Management.

· Supplier Management and Inspection.

· Quality Agreements Management.

· Site Master File Maintenance.

· BPDR and Product Recall.

· Annual Regulatory Guidance Review.

· Support Quality Metrics Maintenance and Quality Council Preparation.

Other Requirements:·

· B.S. degree with at least 3 years of pharmaceutical industry experience or M.S. degree with 1 year of pharmaceutical industry experience.

· A Life science-related major is preferred.

· Excellent communication skills in both English and Mandarin. Familiarity with Korean is a plus.

· Logic thinking and could develop solutions to problems.

· Could work independently and have good time management skills.

Welcome any partners who are interested in taking on the challenge to join us.

https://vip.104.com.tw/job/jobmaster?jobno=13375054