職位描述
Must be able to interface effectively with internal personnel, clients, and auditors, including the USFDA, prepare proper response to any observation. Responsible for all QA functions, including but not limited to document control, releasing testing results, internal/ external audits, as well as personnel training records. Responsible for all lab safety and training issues. Position requires ability to manage and supervise employees. The preparation, review and issuance of various laboratory CAPA status reports, and periodic quality trend updates. Responsible for Exception Management documentation (Deviation, LIR, CAPA, Incidents), accurately and timely performed with documented closure. Internal and external audit key contact and point person. Ensure accurate and timely planning, preparation, review and approval of responses to client audits, schedules, reports, and action plans. This position requires the ability to supervise the department and have good problem solving abilities. Create and revise departmental and test procedures, SOP’s etc. Provide technical support in the maintenance of lab systems and instrumentation. Works with the management group to improve and implement the required quality systems. Works closely with QA staff to maintain and improve Quality Systems. Requires decision-making and analysis of multiple factors in matters involving very complex issues. Demonstrated proficiency with the preparation of quality documents, ability to manage multiple projects and meet critical deadlines. Demonstrated successful interdisciplinary collaboration in a team setting. Requires a M.S. in scientific field is required (Ph.D. prefer) 5+ plus years experience in pharmaceutical, biotech, or medical device industry, with recent and significant experience in the contract testing laboratory industry preferred. Proven track record of success as a QA/RA director. Strong project management skills - ability to take programs from concept to execution, and manage all stages. Superb attention to detail and ability to meet deadlines. Excellent written, verbal, and communication skills. A high level of creativity. Demonstrates strong in-depth clinical, technical and scientific knowledge. Effective administrator who efficiently manages time, resources and workload. Requires decision-making and analysis of multiple factors in matters involving very complex issues. Demonstrated proficiency with the preparation of quality documents, ability to manage multiple projects and meet critical deadlines. Demonstrated successful interdisciplinary collaboration in a team setting. 工作職責：1.有效的與內部人員、客戶、審計，包括美國食品藥品監督管理局的溝通。2.負責監督管理QA的各項工作。 3.負責所有實驗室和培訓工作。4.負責各個文件的管理。5.與QA進行質量體系的維護與完善。6.管理多個項目的能力。任職資格：科學領域碩士（最好是博士），5年以上的制藥、生物技術或醫療器械相關行業的工作經驗。職位概覽 為配合公司實驗室建設及開展檢測業務，杭州艾品公司特此招聘以下各個部門的各類層次人員 (Technician, Associate, Supervisor, and/or Managers): Analytical Chemistry; Analytical Development; Stability; Biopharma; Microbiology; Quality Assurance; Business Development & Marketing; Finance; Human Resources; MIS; ICVS; Corporate Planning & Scheduling; Purchasing & Facilities;注意：成功應聘者將由杭州艾品公司直接聘用并提供薪酬及福利待遇。所有雇員與長三角綠色制藥協同創新中心或其協同成立單位（包括浙江工業大學）將無任何形式的勞務關系。聯系方式 Contact Info： 人事經理 hr@irvinepharma-china.com 請按照下列格式書寫email主題：申請部門_職位_最高學歷_姓名。舉例，一位叫張三的申請者，最高學歷是碩士（MS），申請分析部門(Analytical Chemistry) 的HPLC Supervisor職位，則主題格式為：Analytical Chemistry_HPLC Supervisor_MS_Zhang San。同時，請按照同樣規則將所附簡歷命名。即其簡歷命名為Analytical Chemistry_HPLC Supervisor_MS_Zhang San.If using email to forward resume, please follow the renaming rules below: Department_Position_Highest degree achieved_Last name First name. For example, an applicant named Zhang San wants to apply for the position of HPLC Supervisor in the department of Analytical Chemistry. The highest degree he had is M.S. Then please write email subject as Analytical Chemistry_HPLC Supervisor_MS_Zhang San. On the other hand, please rename the resume to Analytical Chemistry_HPLC Supervisor_MS_Zhang San as well.
