メディカル・バイオ - メディカルGQP・GMP・品質保証・品質管理
メディカル・バイオ - 品質保証

・Assisting in maintaining the QMS on site, implementing local solutions where required
・Work with Quality Systems such as Document Control
・Work within Global eQMS and eDMS/eTMS systems
・Provide support for internal, external (regulatory/Notified Body) and supplier audits
・Lease with Global CAPA team to provide responses to customers of MDx products
・Actively participate as a member of the QA team on site, in partnership with both the Site Head and Global QA Sr. Director
・Lead local project implementations, and/or be part of larger project teams
・Holding a Pharmacist license would be advantageous, but not necessary
・Work with the Warehouse/3PL team on a daily basis to ensure smooth running of activities (including release of product and re-labelling)

■休日：土, 日, 祝日, 夏季休暇, 年末年始

■必須要件
・5 years experience in Quality Affairs, preferably in a regulated IVD/MD/Pharmaceutical/Lifescience company
・Experience in a position in an International Organisation
・Experience in assisting in audits with Competent Authority/Notified Body Audits
・Good spoken and written English ability
・Holder of Pharmaceutical license would be a bonus

■歓迎要件
・Pharmacist license

■職種未経験者：不可