工程运营支持工程师

岗位职责：1. 依据最新的国内外政策、法规及行业指南标准，定期开展暖通空调、纯水注射水、纯蒸汽、特气等系统质量流程回顾和法规差距分析；According to the latest domestic and foreign policies, regulations and industry guidelines and standards, regularly carry out heating, ventilation and air conditioning, pure water injection water, pure steam, special gas and other system quality process review and regulatory gap analysis2. 负责团队偏差、变更、CAPA等质量事件管理；Responsible for team deviation, change, CAPA and other quality event management3. 负责审计前准备工作，配合SME及时答复审计中问题；Responsible for pre-audit preparation and cooperate with SME to respond to audit questions in a timely manner4. 与其它部门质量事件沟通和协调，如变更、偏差的调查实施；Communicate and coordinate with other departments on quality events, such as investigation and implementation of changes and deviations5. 支持团队负责的验证工作，FAT\SAT\IOQ等工作执行；Support team responsible for validation work, FATSATIOQ and other work execution6. 确保团队日常工作符合GMP及相关法律法规；Ensure the team 's daily work complies with GMP and relevant laws and regulations岗位要求：1.本科及以上学历，5年以上GMP药厂工作经历Bachelor degree or above, more than 10 years working experience in GMP pharmaceutical factory2.熟悉制药行业GMP法规要求和质量管理工具，5年GMP质量管理经历，有QA部门工作经验优先Familiar with GMP regulatory requirements and quality management tools in the pharmaceutical industry, 10 years of GMP quality management experience, experience in QA department preferred3.良好的英语听说读写能力，良好沟通协调能力Good English listening, speaking, reading and writing ability, good communication and coordination ability