JOB DETAILS

JOB DETAIL

【Main Duty】
・New project QC/QA work due to the launch of a new factory

【Job Description】
・Registration procedures for manufacturing site with Thai FDA and preparation/submission of related documents
・Project planning and progress management for ISO13485 certification
・Establishment of quality management system based on ISO13485 standards and employee education/guidance
・Management of Halal certification acquisition project and preparation of necessary documents
・Collection of latest pharmaceutical affairs information, dissemination within the company, and implementation of change management processes
・Establishment of manufacturing processes compliant with GMP (GDP) (including IQ, OQ, PQ)
・Creation and management of quality control documents (SOPs, work procedure manuals, etc.)
・Planning and implementation of quality management system transition associated with new factory launch
・Communication and coordination with Thai FDA and pharmaceutical affairs consultants
・Conducting regular internal audits and proposing/implementing corrective measures

Report to Japanese Manager

REQUIRED WORK EXPERIENCE

【Requirement】
・Bachelor's Degree in Pharmaceuticals or related
・Male or Female
・Age between 35 - 45 years old
・More than 5 years of ISO, QMS, RA (Regulatory Affairs) experience
・More than 5 years of experience working with Thai FDA and regulatory consultants, and other related tasks and practical work experience
・Upper Intermediate Level of English　（TOEIC 700 UP）
・No Job hopper

【Advantage】
・Work experience in Japanese companies
・Can speak Japanese
・Project management experience
・Experience in project management
・Experience in Halal certification
・Information gathering work and change management for RA (Regulatory Affairs-centered)