职位描述
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. 工作职责：1、编辑、审查和核准公司校准文件2、编辑、审查、校准和协助验证协议和报告的准备工作3、包括其他控制和规范性文件4、校准、验证和其他培训会议文件的准备、交付5、关于CMI相关的主题6、准备和发布各种技术性报告7、校准、验证和完成定期报告的数据8、根据公司质量标准，确保所有与设备相关资格的准备和完成。9、完成直接管理、教练和开发人员的角色，创建一个团队氛围。10、为新的和现有的分析设备进行开发、维护，校准和预防性维护。11、为所有新的和现有的分析活动做校准和资质确认12、根据所设置的程序和现有的IAL SOPs,GIMPs 和公司质量标准完成设备13、维护详细和准确的记录以满足所有监管和用户的需求14、负责专业技术和支持业务15、在部门内部通过审查和分析部门任务，对团队成员进行定期业绩评估其他职责：1、有良好的时间管理能力，能够履行期限2、能够处理工作上的不明确的地方3、能够适应快节奏的工作氛围4、能够同时负责多个项目5、有很强的抗压性，能够在工作压力下，跟踪和监管多个项目，并能达到目标任职资格：5年或以上医药工作经验。 能够及时发现故障，并熟练的解决故障的能力。优秀的沟通技巧，并且能够将数据呈现给客户和科学会议。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.
