QA Manager
澎立生物医药技术(上海)有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2015-04-11
- 工作地点:上海-浦东新区
- 招聘人数:1
- 工作经验:5-7年
- 学历要求:本科
- 语言要求:英语熟练
- 职位月薪:面议
- 职位类别:药品生产/质量管理 生物工程/生物制药
职位描述
Key areas of responsibility
? Consults with CSO regarding priority of assignment
? Reviews complex projects and must be able to evaluate compliance with special client criteria
? Audits laboratory data for compliance with methods and standard operating procedures and report findings
? Audits sample result tables and analytical reports for completeness and accurate representation of the data and report findings
? Conducts project specific inspections of laboratory procedures to evaluate compliance with analytical methods and standard operating procedures and report findings.
? Client and inspector interaction
? Conducts general facility inspections as assigned
? Conducts audits of vendors and subcontractors as assigned
? Evaluates audit and inspection findings and consults with CSO regarding appropriate course of action and reporting requirements
? Identifies issues which may require follow-up inspection and consult with CSO for scheduling follow-up inspection
? Provides training for new staff
Qualifications
? Good English (verbal and written) skills
? Knowledge of routine analytical methodologies
? Good verbal and written communication skills
? Thorough knowledge of GLP regulations
? Detail oriented and able to deal with multiple and changing priorities.
? Ability to work under minimal supervision. Interactions with supervisor are primarily to inform the supervisor of activities
? Demonstrate proficiency with regulation and guideline interpretation, audit procedures, proper documentation and QA departmental policies and procedures
? Consults with CSO regarding priority of assignment
? Reviews complex projects and must be able to evaluate compliance with special client criteria
? Audits laboratory data for compliance with methods and standard operating procedures and report findings
? Audits sample result tables and analytical reports for completeness and accurate representation of the data and report findings
? Conducts project specific inspections of laboratory procedures to evaluate compliance with analytical methods and standard operating procedures and report findings.
? Client and inspector interaction
? Conducts general facility inspections as assigned
? Conducts audits of vendors and subcontractors as assigned
? Evaluates audit and inspection findings and consults with CSO regarding appropriate course of action and reporting requirements
? Identifies issues which may require follow-up inspection and consult with CSO for scheduling follow-up inspection
? Provides training for new staff
Qualifications
? Good English (verbal and written) skills
? Knowledge of routine analytical methodologies
? Good verbal and written communication skills
? Thorough knowledge of GLP regulations
? Detail oriented and able to deal with multiple and changing priorities.
? Ability to work under minimal supervision. Interactions with supervisor are primarily to inform the supervisor of activities
? Demonstrate proficiency with regulation and guideline interpretation, audit procedures, proper documentation and QA departmental policies and procedures
公司介绍
澎立是2008年成立的港澳台投资公司,提供一站式临床前药效学综合评价服务,即建立一套稳定的各领域动物疾病模型,测试客户候选药物的药效反应,以及医疗器械的生物适用性。服务的疾病领域包括炎症、自身免疫性疾病、肿瘤学、***疾病、代谢类疾病、骨代谢以及骨外科。非人灵长类动物疾病模型是为公司特色型服务代表之一。公司服务对象包括全球制药企业、生物科技单位及医疗器械公司等。公司建立的药效学综合评价服务平台,已在张江高科建成总面积为4300平方米的基地设施,其中包括1600平方米的普通级和SPF级动物房设施。成立后一年内,即先后获得美国实验动物管理认可协会(AAALAC)专业认证、上海市科委颁发的实验动物使用许可证和上海市病原微生物实验室BSL-2资质。公司内大小动物房、手术室均安装高清摄像机,数据信号经由实时影像系统,可为世界各地的合作客户实时监控。为规范实验数据管理,公司成为中国***家购买BioBook软件的CRO,所有原始数据直接录入数据库,无法篡改,达到美国FDA第11部分对于实验数据标准的要求。澎立的管理团队具有丰富的创业和外包服务运作经验,是国内药效学动物模型服务领域的领军人物。
澎立目前已建立起中国一流的药理学平台,立足于为国际国内药企提供国际水准的专业药理药效检测与评价服务,拥有世界领先的各类疾病动物模型、国内最出色的免疫药理平台和先进的人源化动物评价系统。
澎立目前已建立起中国一流的药理学平台,立足于为国际国内药企提供国际水准的专业药理药效检测与评价服务,拥有世界领先的各类疾病动物模型、国内最出色的免疫药理平台和先进的人源化动物评价系统。
联系方式
- Email:Yan.Liu@pharmalegacy.com
- 公司地址:西渡工业园区