职位描述
Responsibilities include assisting the stability system administrator to set up cGMP stability studies for commercial drug product, product/process improvements, marketing commitments, and clinical stability for post-approval studies. Must maintain the stability database, approve all data from the stabilities studies and conduct trend analysis. Will assist with the investigation of OOS, OOT, and atypical stability results. Will assist with the writing of the stability protocol and analytical testing section of the Annual Report, as well as assist with the preparation of FDA filings, and contribute to the development of SOPs for commercial stability.Requires a BS in Chemistry or a related field with 5+ plus years of experience in the pharmaceutical industry with knowledge of regulatory and ICH guidelines requirements for stability studies. Must have some experience in the pharmaceutical stability field, significant knowledge of a variety of FDA and ICH guidance documents for drug products, and a strong analytical background. Must have extensive experience in managing various stability programs with strong understanding and knowledge of ICH guidelines and FDA stability requirements. Must be familiar with working in a cGMP environment. Must be familiar with interpretation of stability data and projecting use-time and expiration date. This job also requires attention to details and strong time management skills. Must demonstrate skills and past experience in managing multiple projects/programs and/or handles multi-disciplinary aspects of projects. The ability to work with analysts at contract laboratories and contract manufacturing facilities is essential. Experience with electronic databases is required. Successful candidates must be proactive and creative, well-organized, and have excellent communication skills. 工作职责：1.协助稳定系统管理员建立药物产品，产品工艺，市场条款和临床稳定性研究的cGMP稳定性研究。2.维持稳定的数据库，并进行趋势分析。3.协助编写稳定性协议，和年度报告中分析测试部分，以及协助FDA申报准备。 任职资格：1. 化学学士学位或相关领域，具有5 +多年的制药行业的稳定性研究监管和ICH指导原则要求的经验。2.熟悉cGMP。3.具备电子数据库的经验。 4.有良好的沟通能力。职位概览 为配合公司实验室建设及开展检测业务，杭州艾品公司特此招聘以下各个部门的各类层次人员 (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：成功应聘者将由杭州艾品公司直接聘用并提供薪酬及福利待遇。所有雇员与长三角绿色制药协同创新中心或其协同成立单位（包括浙江工业大学）将无任何形式的劳务关系。联系方式 Contact Info： 人事经理 hr@irvinepharma-china.com 请按照下列格式书写email主题：申请部门_职位_最高学历_姓名。举例，一位叫张三的申请者，最高学历是硕士（MS），申请分析部门(Analytical Chemistry) 的HPLC Supervisor职位，则主题格式为：Analytical Chemistry_HPLC Supervisor_MS_Zhang San。同时，请按照同样规则将所附简历命名。即其简历命名为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.
