職位描述
The position of Calibration, Metrology & Instrumentation Manager is an essential position to the continued success of the company. Our CMI Manager will have to supervise and directly assist in the effective and efficient operation of the company; specifically, the Manager will oversee COMPANY’s Calibration, Metrology & Instrumentation Systems to ensure that equipment, facilities, instruments, materials, methods and systems are calibrated and validated. The C.M.I. Manager will maintain a “dotted line” working relationship with the QA/RA Director to ensure that C.M.I. activities are in compliance with regulatory requirements and that C.M.I. activities meet or exceed client expectations. The following is a list of job duties to be performed by the CMI Manager (Scientist):•Edit, review, and approve COMPANY Calibration documents•Edit, review, approve, and assist in the preparation of Validation Protocols and Reports •Including other controlled and regulatory documents as needed.•Prepare, deliver, and document training sessions on Calibration, Validation and other •C.M.I.-related topics.•Prepare and issue various technical reports, including tracking and trending of •Calibration, Validation, & Performance data and periodic progress reports.•Ensure all protocols related to the validation and qualification of equipment is prepared and executed in accordance to corporate quality standards•Directly manage, coach, and develop staff in the performance of their duties while creating a team atmosphere.•Develop and maintain a calibration and preventative maintenance schedule for each new and existing piece of analytical equipment.•Ensure that calibration and qualification activities for all new and existing analytical •equipment are performed according to a set schedule and current IAL SOPs, Gimps, and corporate quality standards.•Maintain detailed and accurate records to meet all regulatory and user requirements.•Responsible for technical expertise and support to operations.•Improve deficiencies within department by reviewing and analyzing departmental tasks, responsible for reviewing documents for assigned team members•Conducting performance evaluations on a regular basis•Provide guidance to junior member on various qualification and validation requirements.•Other related duties as assigned.•Must have good time management skills and able to perform to deadlines•Able to deal with ambiguity and able to work in a very fast paced environment•Ability to manage multiple projects is a must•Ensure that project milestones are met and documented•Ability to manage simultaneous tasks, work under pressure, track and monitor progress of multiple projects and follow through to goals. Requirements: This position requires a bachelor degree in chemistry, 5+ years of experience in pharmaceutical. Requires excellent troubleshooting ability, communication skills and ability to present data to clients and scientific meetings. 工作職責(zé)：1、編輯、審查和核準(zhǔn)公司校準(zhǔn)文件2、編輯、審查、校準(zhǔn)和協(xié)助驗(yàn)證協(xié)議和報(bào)告的準(zhǔn)備工作3、包括其他控制和規(guī)范性文件4、校準(zhǔn)、驗(yàn)證和其他培訓(xùn)會(huì)議文件的準(zhǔn)備、交付5、關(guān)于CMI相關(guān)的主題6、準(zhǔn)備和發(fā)布各種技術(shù)性報(bào)告7、校準(zhǔn)、驗(yàn)證和完成定期報(bào)告的數(shù)據(jù)8、根據(jù)公司質(zhì)量標(biāo)準(zhǔn)，確保所有與設(shè)備相關(guān)資格的準(zhǔn)備和完成。9、完成直接管理、教練和開(kāi)發(fā)人員的角色，創(chuàng)建一個(gè)團(tuán)隊(duì)氛圍。10、為新的和現(xiàn)有的分析設(shè)備進(jìn)行開(kāi)發(fā)、維護(hù)，校準(zhǔn)和預(yù)防性維護(hù)。11、為所有新的和現(xiàn)有的分析活動(dòng)做校準(zhǔn)和資質(zhì)確認(rèn)12、根據(jù)所設(shè)置的程序和現(xiàn)有的IAL SOPs,GIMPs 和公司質(zhì)量標(biāo)準(zhǔn)完成設(shè)備13、維護(hù)詳細(xì)和準(zhǔn)確的記錄以滿(mǎn)足所有監(jiān)管和用戶(hù)的需求14、負(fù)責(zé)專(zhuān)業(yè)技術(shù)和支持業(yè)務(wù)15、在部門(mén)內(nèi)部通過(guò)審查和分析部門(mén)任務(wù)，對(duì)團(tuán)隊(duì)成員進(jìn)行定期業(yè)績(jī)?cè)u(píng)估其他職責(zé)：1、有良好的時(shí)間管理能力，能夠履行期限2、能夠處理工作上的不明確的地方3、能夠適應(yīng)快節(jié)奏的工作氛圍4、能夠同時(shí)負(fù)責(zé)多個(gè)項(xiàng)目5、有很強(qiáng)的抗壓性，能夠在工作壓力下，跟蹤和監(jiān)管多個(gè)項(xiàng)目，并能達(dá)到目標(biāo)任職資格：5年或以上醫(yī)藥工作經(jīng)驗(yàn)。 能夠及時(shí)發(fā)現(xiàn)故障，并熟練的解決故障的能力。優(yōu)秀的溝通技巧，并且能夠?qū)?shù)據(jù)呈現(xiàn)給客戶(hù)和科學(xué)會(huì)議。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.
