天津招聘

Accountability：

一、Responsible for the management of multiple regional, cross regional and/or global audit programs.This includes the independently scheduling, scoping definition, planning, conducting and reporting of audits, liaising with stakehoders on audit findings and the follow up thereof. It also incorporates interpretation of findings, providing trending information, root cause analyses and identifying lessons learned for the continuous improvement of the Astellas organization. Manages and follows up on findings and improvement areas.

二、May represent CQA as a Global Quality Lead (GQL) and/or Quality Assurance Representative (QAR) for M&D projects accross Therapeutic Areas. Provides support and consultation to other CRQA functional areas as needed.

三、Responsible for providing unsupervised GCP expert advice to key personnel. This includes and is not limited to:

1. Developing training materials and providing GCP training internally and externally to both small and large professional organizations. It also encompasses coaching of CQA colleagues and other functions on CQA related processes.

2 In case of regulatory agency inspections; review of responses from operations before sending to CQA management for their final review and approval.

3.Interpreting regulatory authorities requirements and advising in the implementation across the Astellas organization.

四、Responsible for regulatory inspection preparation at Astellas entities and/or partners across the region and globally. Analyzes the risks, defines the strategy for inspection readiness and manages the roll out of the inspection readiness program across departments and territories ensuring a harmonized approach.

五、Responsible for identifying outsourcing needs, selecting, managing and evaluating 3rd party QA service providers of which audit and/or consultancy activities have been outsourced. This includes providing training, managing financial information and maintaining effective interfaces to ensure that outputs meet the defined expectations in terms of quality, content and timelines.

六、Supports the development, improvement and maintenance of the Astellas Quality System (both M&D) by identifying root causes to non-conformances related to the processes and/or systems, and by addressing observed gaps in these processes and systems. This includes research of the Pharma Market Place / QA organizations, Regulatory developments and Inspection reports to ensure Astellas meets its strategic objectives in terms of Quality, Business Model and Effectiveness.

七、Manages quality issues related to critical nonconformances, suspicion of scientific misconduct and/or potential fraud. Leads proper corrective and preventive actions identification and rolls out and ensures follow up with effectiveness measures.

八、Manages or supports GCP inspections. This includes communication with Regulatory Authorities, Inspection preparation, inspection hosting, support of CAPA generation and monitoring of follow up to ensure that any risk / nonconformance as identified by inspectors/investogators is adequately addressed and mitigated.

九、Develops and manages interfaces with QA departments of service providers, to ensure QA oversight of the service provider and that any risk to Astellas business is being mitigated.

 

Qualifications：

1.Bachelor’s degree.

2. Minimum of 5 years in pharmaceutical, biotechnology, or related industry.

3.Minimum of 2 years significant experience in Clinical Quality Assurance (except for Japan internal candidates).

4. Minimum of 2 years project management experience, preferably in a highly matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills.

5. In-depth understanding of GCP requirements for both marketed and investigational products.

6. Practical experience and understanding of clinical quality assurance as applied throughout the entire pharmaceutical compound/product life cycle.

7. Effective oral and written communication and presentation skills in English and/or Japanese.

8. Solid understanding of CRQA processes.

9. Proficiency in Microsoft Office.

10. Domestic and international travel at 10-25% as required.

安斯泰来集团介绍：

安斯泰来制药集团是一家总部位于日本东京的研发型制药企业，在全球范围内研发、生产、销售创新型医药产品。我们的使命是不断提升企业价值，致力于通过创新可靠的医药产品为全世界人民的健康做贡献实现我们的存在意义。
安斯泰来制药集团已经在器官移植领域和泌尿领域成为全球专业治疗领域领导者（GCL）。我们结合自身的研发实力，锁定了五个重点研发领域，包括免疫/感染、泌尿、肿瘤、神经科学和糖尿病合并症/代谢性疾病。
在2010财务年度 (2010 年 4 月至 2011 年 3 月) 全球净销售额达 9539 亿日元（97 亿美元）。安斯泰来已经成为日本第二大处方药品公司，全世界排名 20位的制药企业。目前全球员工约 16000 人。 如欲了解更多详细信息，请登录安斯泰来集团全球网站***********************/en/。

安斯泰来中国介绍：
安斯泰来制药（中国）有限公司（以下简称“安斯泰来中国”）是由原“山之内制药（中国）有限公司”于2005年8月更名，再于2007年4月1日，与“藤泽药品（中国）有限公司”合并而成。
安斯泰来中国以“通过提供创新而可靠的医药产品为世界人民的健康做贡献”为经营理念，秉持高度的伦理观和道德观，开展合乎法规的经营活动。在提升企业价值的使命下，发挥创造性，实现业务的持续发展，力图在中国成为受到客户、员工、相关企业、社会团体等利益相关者信赖的企业。
安斯泰来中国是安斯泰来制药集团在中国投资的全资子公司。工厂位于沈阳经济开发区，总部设在北京，在上海、北京、广州、成都、武汉、青岛和沈阳设有分公司，业务范围遍及全国大中城市，全国约有员工1000名。
安斯泰来中国目前在中国上市销售9个产品，涉及器官移植、泌尿、感染、皮肤、消化循环等多个专业领域，其中已经在器官移植和泌尿领域得到广大医生和患者的认可，处于市场领先地位。如欲了解更多详细信息，请登录安斯泰来中国网站**************************.