南京招聘

QA Manager / Director

Duties and Responsibilities

1. Assure compliance of APIs manufacturing with cGMP;

2. Manage the validation program for processes, cleaning, equipment, utilities, facilities, and computer systems, as well as stability programs;

3. Responsible for review and approval of laboratory OOSs and manufacturing deviations and investigations;

4. Provide internal and external auditing;

5. CAPA and management reviews;

6. Carry out performance reviews with QA personnel in accordance with the Company performance management system;

7. Ensure that all GMP related documentation is regularly reviewed and updated in accordance with Company policy;

8. Review and approve product quality review reports;

9. Plan and ensure delivery of training and on-going development for QA personnel.

Requirements

1. Bachelor's degree or advanced degree in a science, engineering, or related field;

2. Thorough knowledge of cGMP;

3. At least five years experience in implementing or maintaining compliant quality systems;

4. At least three years experience in a FDA and/or EDQM approved API Facility;

5. Have excellent interpersonal, problem solving, and communication skills;

6. Ability to read and speak English.

公司前身为国营南京制药厂，成立于1935年，1992年被国务院确定为大型企业，是国家制药工业重点单位之一，2000年由深圳市安远投资集团有限公司资产重组，改制为南京制药厂有限公司，是集研发、生产和销售原料药、制剂和医药中间体为一体的大型医药企业。改制后全面实施企业战略性调整，产品结构调整，整合资产资源，引入新机制、新思路，秉承“关爱生命、再造健康”的理念，坚持“改革创新”的发展思路，不断为提高人类的生活质量和健康水平做出更大贡献。

原料药生产基地位于南京化学工业园，有六个专用及多品种生产车间，多次通过国家和国际官方GMP验收。近二十个品种销往国内和国际市场。

制剂生产基地位于南京新港经济技术开发区，有抗肿瘤药为主的粉水针注射剂的针剂车间和片剂、胶囊、颗粒剂的固体制剂车间。多次通过国家GMP验收，二十多个品种销往全国各地。
 
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