岗位描述
YOUR TASKS AND RESPONSIBILITIES
Responsible for process technology introduction and establishment of new technologies and ensuring robust and repeatable processes 负责工艺技术引入和建立新技术,并确保稳健和可重复的工艺
Responsible for process validation and cleaning validation, etc. 负责工艺验证和清洁验证等工作
Responsible for evaluating and optimizing the current production process, participating in solving technical and quality problems 负责评估和优化当前的生产工艺,参与解决技术和质量问题
Regular collection and analysis of production data 定期收集和分析生产数据
Responsible for process-related deviation investigation, evaluation, and make solutions 负责工艺相关的偏差调查、评估,并制定解决方案
Responsible for process-related change evaluation 负责工艺相关的变更评估
Support for audit 支持内外部审计
Provide professional assistance in preparation and implementation of validation 在准备和实施验证方面提供专业协助
Responsible for understanding updates on CMS, cGMP and other relevant regulations, document revisions and training. 负责了解有关CMS,cGMP和其他相关法规的更新,进行文件修订和培训
Responsible for regular production review to ensure products are of the correct quality and cost and process robustness. 负责定期生产审核,确保产品具有正确的质量和正确的成本、确保工艺的稳健性
Ensure the SOP matches with GMP, Bayer’s CMS and regulations, and all SOPs are completely followed in responsible field. 确保所执行的SOP符合GMP要求、拜耳CMS要求及相关法规的要求;确保公司的SOP 在所负责的领域得到充分的执行
Comply with the company's policies and regulations on EHS, and conduct in line with the requirements of national laws, regulations, and policies. 遵守公司有关EHS的政策和规定,行为符合国家法律、法规政策的要求
Complete other tasks assigned by superior supervisors. 完成上级主管交办的其他事项
WHO YOU ARE
Bachelor or above Degree in reputable university with science and engineer related major. 大学本科及以上学历,理工科相关专业
Have at least 5 years working experience in daily chemical and pharmaceutical manufacture 至少5年在日化及制药公司的专业经验
Have some project management experience 具有一定的项目管理经验
Have systemic GMP knowledge 具有系统的GMP知识
Have good English ability 具有良好的英语能力
Have strong learning agility with "can-do" attitude. 具有较强的学习敏捷性和“能做”的态度
Have strong communication and cross-function cooperation skills 具有较强的沟通和跨部门合作能力
Have good Word, Excel, PPT skills具有良好的Word,Excel,PPT技能
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