验证专员 Validation Specialist
人福普克药业(武汉)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:2014-08-05
- 工作地点:武汉-洪山区
- 招聘人数:2
- 工作经验:三年以上
- 学历要求:大专
- 语言要求:英语熟练
普通话熟练 - 职位类别:药品生产/质量管理 认证工程师/审核员
职位描述
Essential Responsibilities:
1.Monitors the validated state of equipment, facility and utilities to ensure capability to deliver product quality to meet GMP standards and company specifications, to support production operations.
2.Ensures the completion of validation projects and documentation within established timeframes required to meet company objectives.
3.Execute validation projects; interpret data and prepare protocols and reports.
4.Provides technical assistance and handles any questions or concerns from contract customers and regulatory agency representatives in reference to equipment, utilities and facility validation.
5.Reviews various technical and regulatory publications to identify changes and trends in current industry standards and recommends and implements appropriate changes in validation technology to ensure complaince to current industry regulations and practices.
Qualifications:
1. Bachelor degree or above, majored in pharmaceuticals,chemistry or related sciences. 化学制药相关专业专科以上学历;
2. 3 years validation experiences in pharmaceutical manufacturing industry, multinational company experience is preferred;有3年以上制药企业验证工作经验,有跨国公司工作经验优先;
3. Excellent English in reading and writing;良好的英语读写能力;
4. Responsible, excellent communication and coordination skills, strong learning ability.有较强的责任感及良好的沟通能力;
5.Familiar with cGMP and FDA regulation preferred. 参加过FDA或GMP认证者尤佳,具备内审员资格或供应商管理方面的经验者更佳。
公司介绍
公司将提供优厚的福利待遇:
薪酬:有竞争力的薪酬(含绩效奖金及年终奖金)
福利及休假:试用期内开始为员工办理五险一金+定期体检+国家法定假日+一年12天带薪年假(入职即可享受)
交通及食宿:工作餐,为外地或倒班员工提供宿舍
其它:定期组织丰富多彩的员工活动
联系方式
- 公司地址:地址:span武汉市东湖高新开发区光谷生物城生物医药园高新大道神墩二路99号
- 电话:18271875661