职位描述
The Compliance Manager is responsible for Compliance functions to include: document control, regulatory compliance, internal audits, client audits, change control, complaints and personnel training records. This position requires the ability to manage and supervise employees and have good problem solving abilities. Must be able to interface effectively with internal personnel, clients, and auditors, including the FDA; prepare proper response to any observation as required on timely manner. This position is also responsible for all laboratory safety issues to include: safety training, safety audits of the laboratory, and disposal of chemical waste. Excellent communication (verbal & written) and customer services skills required. Excellent writing skills and experience writing technical documentation & reports required. Ability to simultaneously manage multiple tasks/priorities. Excellent problem solving skills/abilities. Good time management and negotiating skills required. Capacity for independent work required. Demonstrated ability to manage multiple projects and meet critical deadlines. Demonstrated ability to work in a team-oriented environment. Must have strong knowledge and experience in dealing with compliance issues in a pharmaceutical analytical laboratories. Will be required to assist with the preparation, execution, documentation, status updates and review of training sessions on a variety of department and regulatory topics. Other related duties as assigned. Must have good time management skills and able to perform to deadlines. 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. This position requires the ability to manage and supervise employees and have good problem solving abilities. Requires excellent troubleshooting ability, communication skills and ability to present data to clients and regulatory agencies. Requires a M.S. Degree in Science with at least 5+ years regulated documentation experience in the pharmaceutical industry. Experience in the contract testing laboratory industry preferred. 合规经理负责合规功能包括:文档管理、遵守规章制度、内部审核、客户审核,变化控制、投诉和人员培训记录。这个职位需要的能力和督导员工的能力,有良好的解决问题的能力。必须能够有效地与内部人员，客户,和审计,包括FDA进行交流;准备适当的应对任何及时观测的要求。这个职位还负责所有实验室安全问题包括:安全培训,实验室安全审计和化学废物的处理。优秀的沟通(口头和书面)和客户服务技巧。优秀的写作技巧和经验写技术文档和报告要求。能够同时管理多个任务。优秀的解决问题的技能/能力。良好的时间管理和谈判技巧。有独立工作的能力。管理多个项目的能力和满足关键的最后期限。证明了在团队的环境中工作的能力。必须有很强的知识和经验在实验室药品分析问题上。可以协助准备、执行、文档、状态更新和审查培训班各种部门和监管的主题。其他相关职责分配。必须有良好的时间管理能力,能够执行期限。确保满足项目里程碑和记录。同时任务管理能力,在压力下工作,跟踪和监控多个项目和完成目标的进展。这个职位需要的能力管理和督导员工的能力,有良好的解决问题的能力。需要良好的故障诊断能力、沟通技巧和能力展示数据给客户和监管机构。需要科学硕士学位至少有5 +年制药行业规范文档的经验。合同测试实验室行业经验者优先。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.
