職位描述
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. 工作職責(zé)：1.協(xié)助穩(wěn)定系統(tǒng)管理員建立藥物產(chǎn)品，產(chǎn)品工藝，市場(chǎng)條款和臨床穩(wěn)定性研究的cGMP穩(wěn)定性研究。2.維持穩(wěn)定的數(shù)據(jù)庫(kù)，并進(jìn)行趨勢(shì)分析。3.協(xié)助編寫(xiě)穩(wěn)定性協(xié)議，和年度報(bào)告中分析測(cè)試部分，以及協(xié)助FDA申報(bào)準(zhǔn)備。 任職資格：1. 化學(xué)學(xué)士學(xué)位或相關(guān)領(lǐng)域，具有5 +多年的制藥行業(yè)的穩(wěn)定性研究監(jiān)管和ICH指導(dǎo)原則要求的經(jīng)驗(yàn)。2.熟悉cGMP。3.具備電子數(shù)據(jù)庫(kù)的經(jīng)驗(yàn)。 4.有良好的溝通能力。職位概覽 為配合公司實(shí)驗(yàn)室建設(shè)及開(kāi)展檢測(cè)業(yè)務(wù)，杭州艾品公司特此招聘以下各個(gè)部門(mén)的各類(lèi)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(yīng)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(zhǎng)三角綠色制藥協(xié)同創(chuàng)新中心或其協(xié)同成立單位（包括浙江工業(yè)大學(xué)）將無(wú)任何形式的勞務(wù)關(guān)系。聯(lián)系方式 Contact Info： 人事經(jīng)理 hr@irvinepharma-china.com 請(qǐng)按照下列格式書(shū)寫(xiě)email主題：申請(qǐng)部門(mén)_職位_最高學(xué)歷_姓名。舉例，一位叫張三的申請(qǐng)者，最高學(xué)歷是碩士（MS），申請(qǐng)分析部門(mén)(Analytical Chemistry) 的HPLC Supervisor職位，則主題格式為：Analytical Chemistry_HPLC Supervisor_MS_Zhang San。同時(shí)，請(qǐng)按照同樣規(guī)則將所附簡(jiǎn)歷命名。即其簡(jiǎn)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.
