导读
PQE是一家总部设在意大利的专业咨询公司，我们拥有数以百计的专业顾问，为全球160多个客户企业提供最高水平的专业知识，自1998以来在制药和医疗器械领域处于领先地位。加入我们，您将获得：
世界各地出差机会
培养你的技能
与最优秀的专业人士一起工作
加入一个年轻的全球化社区，员工平均年龄为30岁，来自超过25个国家和地区
全激励薪酬制度，包括薪资，技能发展，和灵活的福利
Prepares and conducts GMP/GDP audits to suppliers/contractors as guided by PQE TPA team.
Conducts audits in accordance with PQE standard operating procedures and client's directives.
Evaluates and ensures that Quality Management System, Personnel, Premises, Equipment & Systems, Processes, and Documentation of suppliers/contractors are in compliance with GMP requirements.
Escalates immediately to PQE and Client's Management any critical compliance issues.
Communicates audit results immediately to PQE and Client's Management.
Timely documents the audit through a comprehensive audit report.
If required, manages post-audit activities by reviewing and following up on the auditee CAPA plan.
Coaches and supervises junior auditors, if requested.
BS/BA with 5-7+ years of related experience in Biotech/Pharmaceutical industry, 2-5 years of audit experience in GMP environment.
Respectful of ethical principles
Open-minded
Diplomatic and collaborative
Observant and perceptive
Tenacious
Decisive
Self-reliant
Acting with fortitude
Open to improvement
Culturally sensitive
Project management
Prioritization skills
Fluent English (at least B2/C1 Level)
Availability to travel domestically and abroad. This position requires approximately 50% travel. Excellent use of major productivity SW (e.g.: MS Office)
API manufacturing (including high potent compounds)
Finished Product manufacturing
Sterile productions (both APIs and FPs)
Excipient manufacturing
Pharma distribution (APIs and FPs)
Extensive experience in the application of Quality Risk Management and Continuous Improvement
Sufficient expertise on analytics and QC Labs processes
Direct experience in EU and US markets (former roles in multinational companies is a preferred requirement)
原料药生产（包括高效化合物）
制剂生产
无菌生产（APIs及FPs）
辅药生产
制药物流相关(APIs及FPs)
质量风险管理及质量体系提升有丰富经验
Technical Degree (Pharmacy, Pharmaceutical Chemistry, Microbiology, Chemistry, Engineering)
Minimum of 10 years' experience in the Pharmaceutical industry (covering managerial or key roles)
Top knowledge of the main rules/guidelines/best practices/expectations of CFDA (China)
Deep knowledge of the main rules/guidelines/best practices of the major regulated markets (EU and US)
Suppliers/Vendor management (e.g.: qualification audits, monitoring etc)
knowledge on Quality Risk Management and Continuous Improvement
Expertise on analytics and QC Labs processes
Experience in the preparation and hosting of Authority inspections
Operational Excellence skills / Lean-Six Sigma certifications (nice to have)
工科背景:药学,制药化学,微生物学,化学,工程学
拥有制药工厂十年以上经验(在管理及其相关重要岗位)
充分熟悉中国食品药品监督管理总局的主要规章/准则/方案/预期
在主流法规/指南/法规市场拥有广泛的知识(EU 及US 法规)
有准备和参与官方检查的直接经验
供应商的管理
质量风险管理及质量体系提升有丰富经验
有质控分析和QC 实验室的相关专业知识
在相关监管部门进行质检之前有充分准备的经验
卓越运营技能/有六西格玛认证证书（最好具备）
Team-play 团队合作
Full availability to travel 适应差旅
Project management (nice to have) 项目管理能力（最好具备）
English(fluent):mandatory
Other languages: nice to have
英语流利：必备
其他语言能力（最好具备）
Collaboration in project teams
Various roles in the validation process including the creation and execution of qualification protocols (IQ, OQ, PQ),
Development of validation plans
Performance of risk assessments.
In addition, this role requires close interaction with clients and the ability to work and communicate with both team members and external stakeholders.
项目团队的合作
在工作中依据高级项目经理的指导进行相关验证工作，（IQ,OQ,PQ）
在高级专家的指导下对验证文件和测试文件进行整理
对风险评估有一定了解
有一定沟通能力
Smart, motivated and open to new experience
Technical Degree (Engineering, Chemistry, Informatics, Physics, Mathematics) Or Language Degree
头脑聪慧，积极上进，能够接受新东西
技术背景（工程，化学，信息，物理，数学）有语言背景
Experience in Pharmaceutical Sector
Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.
制药行业经验
应聘者需要喜欢挑战，容易接受新知识，有一定的领导能力。
English (fluent) mandatory
英语流利（必须）
英语好，有CSV背景
生物科学背景，有IT相关能力及知识
项目团队的合作
能够与外国同事沟通交流完成公司日常IT系统硬件软件的运行及维护
有一定沟通能力,在工作中依据高级项目经理的指导进行相关工作
在高级专家的指导下对验证文件和测试文件进行整理
Smart, motivated and open to new experience
Technical Degree (IT)
Fluent English
头脑聪慧，积极上进，能够接受新东西
技术背景（IT专业）
英语流利，能进行无障碍沟通交流
Experience in Pharmaceutical Sector
Two years working experience
Our collaborators are engaged, developed, challenged and well-rewarded for performance.
We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders
制药行业经验
两年工作经验
喜欢挑战，容易接受新知识，有一定的领导能力
English (fluent): mandatory
英语流利（必须）
／End.
PQE Group，始于1998年，ISO 9001认证的完整质量解决方案供应商，从美国到日本，18处办公室遍布全球。我们积聚了数百位行业专家，以25种语言、全球化的思维、先进的实践经验，为您提供数据可靠性保障、数字化管理、确认和工程、GxP合规、药政事务、和第三方审计等方面的服务。
