质量体系专员QS Specialist-level 3

主要职责:执行质量体系相关的日常工作事务，包括协调、维护和执行质量体系以符合GMP的要求。This is a Quality position (at a senior level) experienced in administering the day to day activities for the Quality Systems department at the Wuxi site of SEQENS.

职责1:确保遵守相关程序和工作指南，正确、有效、高效的管理和执行变更控制、客户投诉和年度GMP培训等相关的活动;

Mission 1: To ensure that the management and implementation activities associated with Change Control, Customer Complaint, and Annual GMP training are executed accurately, effectively and efficiently in accordance with all relevant procedures and work instructions.

· 独立或者和团队一起，在要求的时限前，积极主动的完成工作;Proactively complete the work, independently or as a team, in an accurate and timely manner

· 确保所有工作的执行都符合良好文件记录规范和数据完整性的要求;Assure all the work are conducted in accordance with Good Documentation and Data Integrity practices

· 作为质量部门的代表，指导和协助内部同事/客户按照批准的程序来执行质量体系的相关工作;Be the quality representative to assist the internal colleagues / customers to navigate through the quality systems to execute the work in accordance with approved procedures

· 积极主动的协调/跟进相关部门和负责人，获得相关的信息来完成工作;Proactively coordinate / follow up with various departments and stakeholders to obtain the relevant information to complete the work processes

· 完成更新和起草相关的SOP和WI，当需要时;Update and creation of SOPs and WIs, when required

· 创建适当的培训文件，按照规定的时限为相关人员提供培训;Establish appropriate training materials; coordinate and deliver the training to applicable employees as per defined timelines

· 协助完成质量体系发起的项目，来达成质量和业务目标;Support the initiatives / projects of the Quality System department to achieve the defined quality and business objectives

职责2:支持本地法规事务，包括但不限于：

Mission 2:To support the local Regulatory Affairs, which include but are not limited to:

· 为总部RA提供要求的相关信息;Collect relevant information to support Corporate RA team’s request

· 协助维护本地法规相关的证书;Support the maintenance of local regulatory relative certificates

· 保持符合本地法规部门和药监部门关于药品生产的要求;Stay current with local regulatory affairs and NMPA requirements for pharmaceutical manufacturing

· 协调其他与本地法规和药监部门相关的活动;Coordinate the activities associated with the local regulatory affairs and NMPA

职责3:按照要求,支持质量体系的其他工作活动、项目/方案和各项审计相关的活动，比如：

Mission 3: To support, when required, other QS work activities, projects / initiatives and various audit related activities, such as:

· 维护和报告质量体系相关的KPIs;Maintenance and reporting of Quality Systems related KPIs

· 文件和GMP记录管理活动;Documentation and GMP records management activities

· 参加客户和法规审计相关活动.Participating in customer and regulatory audit related activities

任职资格如下：

1、至少，大学本科学历，制药工程相关的专业（比如，生物、化学、制药） At minimum, a Bachelor’s degree of Sciences or Pharmaceutical Engineering or equivalent (e.g. Microbiology, Chemistry, Pharmacy.

2、至少5年质量保证，或质量体系，或质量运行相关工作经验，具有制药行业相关工作经验，和/或本地法规事务相关工作经验的优先。At least 5 years of work experience in Quality Assurance or Quality Systems or Quality Operations, preferably in the pharmaceutical industry, and / or local regulatory affairs related work experiences.

3、注重细节，确保数据和信息的准确性。Detail oriented to assure accuracy of data and information.

4、具有相当的时间管理能力和组织协调能力，能够适用快节奏的工作环境。Proven time management and organizational skills to work in a fast-pace environment.

5、 有效的沟通技能。Effective communication skills with colleagues at all levels.

6. 能够在工作环境中进行英语交流（书面和口头）Capable of English communication (written and oral) in a work environment.

7. 精通计算机。Proficient in computing (e.g. Microsoft Word, Excel, PowerPoint, Visio, etc.)

8. 熟悉数据分析相关的工具。Working knowledge of various tools for data analysis.