{ Key Responsibilities and Major Duties } 1. Ensure that a Quality Management System is implemented and maintained in the local market, including: →Acts as the local Authorized Person responsible for GDP in accordance with Market regulatory requirements →Maintains Quality System Documentation: procedures and records o Policy/Directives/SOPs impact assessment and implementation o GDP and Local regulations impact assessment and implementation →Ensures initial and continuous GMP/GDP training programs are implemented and maintained, including product identification and avoidance of falsified →Develops and maintains locally the Quality Manual/Site Master File →Ensures that relevant customer complaints are dealt with effectively →Performs periodic Self-inspections according with the self-inspection plan and puts in place necessary corrective measures →Ensures implementation of Deviation and CAPA management →Ensures implementation of the Change Control management →Coordinate the Quality Management Review/Quality Council of the Market →Reports quality metrics and Implements adequate action plans for metrics achievement when necessary 2. Ensures implementation of following Quality Operations: →Suppliers management oversight: Quality Agreements, approving any local subcontracted activity which may impacts product quality, evaluate and confirm the overview of the supplier qualification status →Product Quality status and batch release or approval to the market →Support compliance/quality issues with the impacted market team →Ensures On Hold products request are observed →Coordinates and promptly perform any market action operation, recall, for medicinal products. Mock recalls →Decides on the final disposition of rejected, recalled or falsified products →Approval of the returns to saleable stock, according to requirements →Support Supply Chain to avoid Back Orders →Provide quality input on shortage situations and oversight reporting to Health Authority →Medical samples Quality distribution oversight →Supports of sampling requested by HA (product, procedures, reference substances) →Keeps appropriate records of any delegated duties 3. Facilitate that requirements are implemented in the Local Distribution Centre/ Asia Distributors (as required) for: →Warehousing facilities →Secondary packaging facilities →Transportation processes 4. Quality Risk Management →Coordination and preparation of Quality Risk Management →Participate in the periodic Business Review with the DC 5. Inspections and Regulatory Surveillance →Maintenance of the Wholesale Distributor License with Regulatory agency →Import certificates, when requested →Support the Global Quality Audits in the market →Preparation of HA inspection in local entity and leading HA inspection →Anticipate the new directives (Regulatory surveillance) 6. Site PIC/s GMP registration, maintenance and renewal ***Contract position***

Adecco藝珂是全球最大的國際性人力資源服務公司，藝珂能根據企業的需求，提供最好的專業人才招募及人才派遣等相關人力資源服務，協助企業跨越文化、地域及語言上的限制，招募到最適職及可信任的人才。 藝珂總部設於瑞士，為《財富》（Fortune）排名全球前500大公司，目前已有5,500多家分公司遍佈於超過世界60個主要國家及地區市場，全職員工將近33,000名，每天更有約700,000名的約聘派遣人員為各公司提供服務，而在紐約、巴黎和蘇黎士，藝珂均為公開上市公司。 藝珂台灣分公司則成立於1989年，除了為台灣企業提供人才搜尋的服務外，更為企業的人力資源管理提供一個全方位的服務規劃，並根據專業範疇劃分全新的全球服務領域，得以專注並善加利用產業洞察力、提供作法和全新創舉。 多年來的努力，如今藝珂不僅是台灣最大的人事顧問公司，在台北、新竹、台中、南科、高雄皆有服務據點，深受國內外企業的好評與信賴。其服務市場亦遍及大中華地區與當地分公司密集合作，以最密集的服務網及最完整的服務內容，提供各類產業及大、中、小型企業更多元的人才資源服務，協助企業經營領域的擴展，同時讓求職者有更彈性多元和跨地域的求職空間。 Adecco藝珂根據專業範疇劃分新的六大專業領域，藉由深耕產業知識與人脈，在系統化、專門化的服務之下，進而提升服務能力、滿足客戶需要並嘉惠夥伴。許多求職者面對多變職場的壓力與刺激，採取組合式生涯，藝珂可隨時提供豐富資源和資訊，讓求職者隨時找到最適當的工作。 Adecco Professional Support 六大專業領域 行政管理 (Office) 業務及行銷 (Sales & Marketing) 財務及金融 (Finance & Banking) 工程及科技 (Engineering & Technical) 資訊科技 (Information Technology) 人力資源相關服務 (Human Capital Solutions) 藝珂據點 台北總公司 02-5552-6168 新竹分公司 03-620-1558 台中分公司 04-2301-0781 南科分公司 06-510-6999 高雄分公司 07-226-2060 欲知更多藝珂訊息，請至藝珂官網 www.adecco.com.tw