南京招聘

Accountability：

一、Quality control of clinical trial

1. Establish communication with global quality management team, develop and maintain clinical trial quality control system in line with global new standard and procedure, such as study risk based monitoring

2. Review clinical study documents and conduct co-monitoring according to company requirement.

3. Develop verification process that will allow identification of abnormalities / inconsistencies.

4. Suggest how to improve the quality based on the current clinical trials situation.

二、SOP development /maintenance

1. Join global SOPs development and update, harmonize local SOPs with global SOPs, ensure local standards and procedures are consolidated with global SOPs

2. Develop and update SOP according to related laws, regulations and company requirement.

三、Training of ACN DD / CRO CRAs and relevant members

1. Develop and maintain training system, provide training to new and existing staff to ensure their qualification

2. Provide training based on the inspection / audit results

3. provide training according to GCP and company policy

4. Provide training of Chinese clinical trials related regulations

四、Supports of inspection/audit conducted by health authority/internal auditor

1. Take note to new local regulations and industry standards, such as new GCP, self inspection requirement etc., communicate with global team and industry organizations to assess the impact to clinical operation

2. Support and ensure inspection/audit readiness, appropriate conduct and follow up, serve as the primary liaison with QA/inspectors to control the activities during inspection/audit

3. Arrange the audit with ACN DD members based on internal CQA/health authority request.

4. Support document preparation for Audit

5. Draft / review the response to audit report (eg CAPA)

6. Follow up CAPA

五、People management

1. Coach and provide training to improve the QC staff’s ability

2. Understand the QC staff’s career development expectation and retain excellent talent for the company

Qualifications：

一、Education

1. Master/Bachelor

二、Skills

1. Demonstrated communication, negotiation/influencing, and social skills with a sense of diplomacy, relating to peers.

2. Very good active and passive skills in English, leading and attending meetings, presenting and training.

3. Working knowledge of China drug development processes.

4. Understanding the impact of regulatory requirements and guidances / internal SOPs / PM concepts.

5. Works effectively under pressure, accurate and patient.

6. Proficient in utilizing and creating outputs using relevant software. Easily adapts to change.

三、Experience

1. 5 years or above CRA project management experience

2. at least 3 years quality management related experience

3. knowledge of medicine or pharmacy

4. have team spirit, relevant computer skills and organizational training skills

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**************************.