天津招聘

JOB PURPOSE
To assist the IQC manager in the operations in QC laboratory and ensure that analytical methods are validated and followed and that the products released meet the specifications. Write the materials specifications and analytical test methods. Ensure the routine monitoring of the facilities is correctly performed.

KEY ACCOUNTABILITIES

1. Manage the QC chemical & microbiology laboratories ensuring that the equipment is functional (calibrated and well maintained) and suitable for analytical testing.

2. Write and maintain documents such as Analytical Methods, Material Specifications, Standard Operating Procedures, etc.

3. Manage workload and resources to ensure timely release of product. Manage the sampling and analysis of raw materials, intermediates, work-in-process, finished products, routine monitoring samples and others (including water, compressed air etc.). Ensure that testing is carried out in compliance with specifications, Pharmacopoeia requirements and the cGMP and analyse the trend of the analytical results. Ensure the OOS investigation is conducted properly.

4. Ensure that reference standards as well as standard solutions are suitable and maintained according to the cGMP. Maintain and control the inventory of chemicals and consumables, Microbiological Media, stock controls and biological Indicators including toxic reagents, ensuring that the budget is respected.

5. Write the protocols and perform the qualification of the laboratory equipment/instruments and the validation of new analytical methods. Manage the stability program. Ensure the retention samples management meet requirements.

6. Ensure all the imported material/product are sampled and analysed by BIDC according the local requirements. Maintain the file of BIDC CoAs.

7. Keep close relationship and communication with other departments to ensure proper execution of the production plan. Lead and motivate the analysts for a continuous improvement of GMPs as well as EHS awareness. Be the safety contact for the laboratories.

8. Perform analytical method validation, establish quality standards for finished products and APIs and excipients.

JOB-HOLDER ENTRY REQUIREMENTS

1. At least BA degree in Chemistry or Pharmaceutics or chemical related majors. Previous GMP trainings a must. Good knowledge of China SFDA regulations on drug products.
2. At least 5 years of analytical working experience (testing and method validation) drug or health food with at least 2 years of people and project management experiences.
3. Familiar with operations/maintenance programs of analytical equipment’s: HPLC, dissolution, UV-Spec, AA, etc.
4.Must be problem solving oriented.
5.Good English writing and spoken as well as a good knowledge of Chinese and international GMP are required.

集团概况
尊重：我们认同和尊重员工、患者和合作伙伴的需求及其多样性。我们承诺在互信的基础上开展透明且具有建设性的沟通。

创新：我们鼓励所有的员工和合作伙伴发挥创业精神、探索创新思路。

信心：我们充满自信，恪守原则。我们一心一意、永不气馁，敢于挑战常规。

齐心：我们对我们的行为、我们的员工、我们的患者和我们生存的环境负责。共同的责任让我们走到一起。

正直：我们承诺，坚持最严格的道德操守和质量标准，决不妥协。

赛诺菲安万特（北京）制药有限公司
赛诺菲-安万特(北京)制药有限公司坐落于北京经济技术开发区，占地4万多平方米，现有员工100名左右。公司于2002年12月通过了国家GMP认证，认证范围包括小容量注射剂的分包装，片剂和胶囊的分包装和生产。主要产品分别是亚莫利（片剂1mg,2mg),用于治疗2型糖尿病;瑞泰(片剂5mg),用于治疗高血压;易善复(胶囊和针剂),用于治疗急性和慢性肝病。公司产品于2003年3月开始投放国内市场。