setup the quality control program from product pilot to serial production lots

be knowledgeable about the plant equipment and environment for optimum performance in equipment and environmental cleaning. liaise with production personnel to carry out the validation and routine monitoring for environment and critical systems (air system, water system, etc.)

execute the qualification/ validation, routine monitoring and maintenance for lab equipment

conduct the routine monitoring for sterilization vendor, liaise with serialization vendor to carry out the product sterilization and sterilization process validation

establish quality specification, sop, and working instruction, according to good laboratory practice (glp), along with respect to corporate and local quality requirement

establish GMP related sop. train and qualify the process inspector all quality control activities, immediately report all observations of GMP non-conformances during the routine monitoring

conduct the final product release and routine product quality sampling test (bio-burden test, sterility test, lal test, to residual test, etc.)

establish& carry out the cleanroom product system release system.

conduct the related quality deviations handling, change controls and complaint investigation.

assist related departments (such as the production department) to finish related validation activities, ensure the effectiveness and suitability of the validation activities;

calibration and maintenance management for lab equipment.

analysis the lab quality trend(defect rate, data trending, etc.) on an ongoing basis, improve the product quality performance level with implementation of continuous improvement tools.

maintain and ensure safe working conditions

bachelor degree, majored in science of microbiology, biochemistry, pharmaceutical, food etc.

minimum of 3 years working experience in microbiological laboratory, above 3 years in eu/us company is preferred

food, dairy or pharmaceutical experience is preferred

at least 2 years working experience in GMP environment of medical industry is preferred

good English communication both in oral and written

familiar with iso9001, GMP, GLP and validation

be familiar with micro lab internal quality controls

familiar with quality control statistic tools, SPC, MSA, GR&R etc.

good computer and software skills

上班地址：Suzhou

华德士中国

华德士于2008年进入中国市场，目前在上海、北京和苏州设立有分公司。我们凭借专业素养和丰富经验为各大公司招聘顶尖双语人才，并于最近被评选为***国际人才招聘顾问机构。

我们的顾问都有相关行业的从业经验，因此能更深刻地理解您的需求。我们主要为以下领域招聘中高级专业人才：会计与财务、银行与金融服务、工程与运营、高层管理、人力资源、信息技术、市场营销、采购与供应链等领域。

https://www.robertwalters.cn/zh/about-us.html