1. 채용 포지션: QA(대리과장급)
-Validation activities management including but not limited to cleanroom , equipmentand sterilization.
-Change control and CAPA
-Track and monitor the events.
-Audit: internal, external and suppliers
-Training for GMP/Quality
-Document control, data integrity and quality management system maintenance.
-Analyze and report trends in related to product quality and environment con trol.
-Complaints and daily processes to ensure issues are being addressed in a timely and
thorough manner, and conform to the company complaint policy and procedures.
-Liaise, drive and facilitate quality improvement projects.
-Raw material, in process quali ty control and finished goods inspection, process
control handling including quality data collection & analysis, and quality issue
-Manage the measuring and monitoring equipment and maintain the inspection
equipment and gauges.
-Other duties a s assigned and/or contained in annual goals and objectives.
-대졸이상 업종(바이오, 생명과학, 화학) QA,QC 4년이상 경력자
-Familiar with relevant regulatory statutes and industry standards, such as ISO 13485,GMP.
-E xperience in quality control regarding EM in clean room and sterility and process/equipment validations is preferred.is preferred.
-Qualified auditor with excellent audit skill preferred.
-해외여행에 결격사유가 없는분 / 영어회화 능숙한 분