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：1、編輯、審查和核準公司校準文件2、編輯、審查、校準和協助驗證協議和報告的準備工作3、包括其他控制和規范性文件4、校準、驗證和其他培訓會議文件的準備、交付5、關于CMI相關的主題6、準備和發布各種技術性報告7、校準、驗證和完成定期報告的數據8、根據公司質量標準，確保所有與設備相關資格的準備和完成。9、完成直接管理、教練和開發人員的角色，創建一個團隊氛圍。10、為新的和現有的分析設備進行開發、維護，校準和預防性維護。11、為所有新的和現有的分析活動做校準和資質確認12、根據所設置的程序和現有的IAL SOPs,GIMPs 和公司質量標準完成設備13、維護詳細和準確的記錄以滿足所有監管和用戶的需求14、負責專業技術和支持業務15、在部門內部通過審查和分析部門任務，對團隊成員進行定期業績評估其他職責：1、有良好的時間管理能力，能夠履行期限2、能夠處理工作上的不明確的地方3、能夠適應快節奏的工作氛圍4、能夠同時負責多個項目5、有很強的抗壓性，能夠在工作壓力下，跟蹤和監管多個項目，并能達到目標任職資格：5年或以上醫藥工作經驗。 能夠及時發現故障，并熟練的解決故障的能力。優秀的溝通技巧，并且能夠將數據呈現給客戶和科學會議。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.
