职位描述
职位描述: 工作职责:负责清洁验证工作。Responsible for cleaning validation.负责清洁验证管理规程的制定及修订。Responsible for formulating and revising of the SOP for cleaning validation.指导QC进行清洁验证取样回收率试验。Guide QC for recovery study of cleaning validation.负责清洁验证方案和验证报告的起草或审核。Responsible for draft or review of the cleaning validation protocols and reports.组织协调清洁验证的有序进行。Organize and coordinate the conduct of cleaning validation in order.参与验证过程中偏差的调查分析及变更的评估。Participate in deviation investigation, analysis and change assessment.人员资质:本科以上学历,生物学和药学相关学科。Bachelor Degree above,major in biology or pharmacy.3年以上制药及验证工作经验。At least 3 yearsof working experience in pharmaceutical or validation.熟悉 FDA 欧盟以及ISPE PDA等法规指南对于验证要求。Be familiar with the requirements of validation according to the regulations and guides of FDA, EU etc.良好的英语听说读写能力,熟练计算机使用。Well verse in spoken and written English. Good at computer software.有较强的分析问题能力及良好的沟通技巧、工作认真、细致,具有良好的团队合作精神。Excellent communication, problem-solving, and organization skills, attentive, careful and meticulous, with strong team-work skills. 职能类别: 生物工程/生物制药