上海招聘

1. Auditing（30%）
Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and relevant stakeholders (e.g. Clinical Operations, PV), and interacts with various teams to ensure corrective and preventative actions are taken to bring audit observations to closure as applicable. Activities may include routine and directed audits of investigator sites, vendors, regulatory documents and marketing applications, third party collaborations and due diligence activities.
准备、实施QA稽查，生成稽查报告，将结果传达给相关QA管理层和相关利益相关者(如临床运营, 药物警戒)，并与各小组进行沟通，以确保采取纠正和预防措施，在适当时关闭稽查发现。活动可能包括对研究中心、供应商、监管文件和上市申请、第三方合作和尽职调查活动的常规和直接稽查。

2. Risk Management (20%)
Perform risk assessment and evaluate in area of responsibility.
Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk based QMS assessments and to support the implementation of associated risk mitigation strategies.
在职责范围内进行风险评估和评估。
主动识别分析并利用质量指标和数据来识别潜在的趋势和风险，以处理和完成基于风险的QMS评估，并支持相关风险缓解策略的实施。

3. Issue Management (10%)
Supports Significant Quality Issues management, including assessment of potential root causes and CAPA development.
Ensures appropriate and timely escalation of systemic problems and quality issues, including potential misconduct or issues of significant deviation with projects/products, to the upper management for immediate and long-term resolution.
支持重大质量问题的管理，包括潜在根本原因的评估和CAPA的制定。
确保系统问题和质量问题的适当和及时地向上层管理部门通报，包括潜在的不当行为或与项目/产品

4. Controlled Document Management (15%)
Supports the development of SOPs to ensure alignment with local laws and regulations.
Participates in the development/enhancement of QA procedures, guidance documents and audit tools.
对于sop的制定提供支持，确保与当地法律法规保持一致。
参与QA程序、指导文件和稽查工具的开发/改进。

5.Inspection Readiness / Inspection Management (5%)
Actively involved/leading pre-inspection preparation activities in collaboration with business customers/partners.
Prepares and educates internal and external business customers/partners (incl investigator site staff) on inspection management.
Hosts and /or participates in inspection(s).
Responsible for inspection response management and tracking through resolution.
Actively participates in lessons learnt/shared learning.
与业务伙伴合作，积极参与/领导核查前准备工作。
准备和教育内部和外部的业务伙伴(包括调查现场的工作人员)进行核查管理。
主持和/或参与核查。
负责核查回复的管理和跟踪。
积极经验教训的分享学习。

6. GCP and/or GVP & QA Expertise (5%)
To provide GCP and/or GVP compliance interpretation, consultation, training. Act as a subject matter expert to respond to GCP and/or GVP compliance inquiries.
提供GCP及/或GVP合规性解释、咨询、培训。作为主题专家回应GCP及/或GVP合规咨询。

任职要求：
1.Knowledge of ICH guidance, China local regulations, new drug regulations and current industry practice 具备ICH指导，国内法规，新药规范等专业知识.

2. Knowledge of Quality Management Systems principles, including policies, procedures and processes 具备质量管理规范等相关知识，包括制度，程序及流程.

3. Proficient written and spoken English language skills 良好的英语听说读写能力.

4. Education/Certification (教育/认证):
Bachelor's Degree or equivalent in scientific or health related area 本科或同等学历，科学或健康相关专业.

5. Professional Experience (专业从业经历):
A minimum of 8 years of previous Pharmaceutical Industry experience is required, with at least2~3 years of previous Quality related experience. Experience in conducting a broad range of audits is preferred. 至少8年制药行业工作经验，至少2~3年的质量相关工作经验。有广泛稽查经验者优先。

    江苏晨泰医药科技有限公司成立与2017年1月，是一家专注于研发创新疗法以满足医疗急需的临床研究阶段的公司。公司的管理团队在肿瘤治疗、临床运营、注册事务、医药营销等医学研究方面有几十年经验。目前在上海、北京设有办事处。
    2018年6月19日，晨泰医药科技有限公司（“晨泰医药”）宣布其成功完成A轮6,500万美元融资的首次交割，共计3,700万美元。这次融资由国内知名风险投资机构启明创投领投。其他几家知名的投资公司也参与了这一轮融资，其中包括泰福资本和醴泽健康产业投资基金。A轮募资将用于开展公司主要在研产品AZD3759的国际多中心II期临床试验，和进一步丰富公司的产品管线。
   为致力于全球化创新药物的临床开发。公司与国际大型制药公司合作, 确保产品的前期研发工作扎实可靠。利用公司强大的科学顾问和管理团队，制定最优化的创新药物开发策略，注重研发/市场/知识产权保护的多维布局。具体试验操作和业务开展方面与国际/国内顶尖的CRO/CMO/医院/研究院所合作，使用公司完善的项目管理体系来协调、监督项目合理有序开展。