职位描述
职位描述: 岗位职责:负责工艺验证工作。Responsible for process validation. 负责工艺验证管理规程的制定及修订。Responsible for writing and revising of the SOP for process validation. 负责制定工艺主计划。Responsible for writing the process validation master plan. 审核工艺验证前的风险评估。Review risk assessment before process validation. 负责验证方案和验证报告等验证文件的审核.Responsible for reviewing the validation documents, such as validation protocols and validation summary reports. 负责工艺特征研究方案和报告的审核。Responsible for reviewing the process characterization studies protocols and reports. 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.任职要求: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年以上制药或者验证工作经验,包括1年以上工艺验证工作经验。At least 3 years of working experience in pharmaceutical or validation, including at least 1 years of process validation. 熟悉CFDA, FDA ,欧盟以及ISPE PDA等法规指南对于验证的要求。Familiar with the requirement of validation according to the regulations and guidelines of CFDA, FDA, and 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, and strong team-work skill. 职能类别: 生物工程/生物制药