质量助理

职责 Responsibilities：
1. 质量体系与文件管理辅助工作 / QMS & Document Management Assistance
• 协助维护公司GMP质量管理体系，跟进生产、仓储、检验环节的日常合规落地，配合完成内部GMP自查、体系常态化优化工作。 / Assist in daily maintenance of GMP quality management system, supervise compliance of production, warehouse and laboratory links, and support internal GMP self-inspection and continuous system optimization.
• 协助质量体系SOP、质量标准、记录表单等文件的编制、修订、校对、归档及发放作废管理，确保文件合规、版本统一。 / Assist in drafting, revising, proofreading, issuing, archiving and invalidating quality SOPs, specifications and records to ensure compliance and version consistency.
• 学习并落实数据完整性管理要求，协助监督生产、检验全流程数据记录真实、完整、可追溯，规避基础质量风险。 / Learn and implement data integrity requirements, supervise the authenticity, integrity and traceability of production and testing data to prevent basic quality risks.
2. 质量异常闭环辅助管理 / Quality Non-conformity Closed-loop Management
• 协助收集、整理生产及检验过程中的偏差数据，配合完成偏差调查、原因梳理、整改措施落地跟进及资料归档。 / Collect and sort out production and testing deviation data, assist in deviation investigation, root cause analysis, corrective action implementation and document filing.
• 协助开展质量变更初审、资料汇总、风险辅助评估工作，跟进变更落地执行情况，完成闭环记录。 / Support preliminary review, data collection and risk assessment of quality changes, follow up change implementation and complete closed-loop records.
• 配合参与OOS/OOT检验超标、超常结果的调查工作，整理调查资料，协助落实CAPA纠正预防措施并跟踪闭环。 / Participate in OOS/OOT investigation, sort out investigation documents, assist in formulating and closing CAPA plans.
3.供应商审核和放行支持 / Supporting for supplier audit and release
• 协助开展供应商质量资料审核、资质归档、日常质量动态跟进等基础工作。 / Support supplier quality document review, qualification filing and daily quality performance follow-up.
• 负责批生产记录、批检验记录的初步审核、整理归档，协助完成产品放行前置核查工作。 / Conduct preliminary review and archiving of batch production and testing records, assist in pre-release verification of finished products.
4. 合规对接与培训配合 / Compliance Support & Training Assistance
• 协助整理药监核查、第三方审计、客户审计的备查资料，配合完成各类迎检准备及缺陷整改资料汇总。 / Prepare documents for regulatory inspections, third-party and customer audits, assist in inspection preparation and non-conformity rectification filing.
• 协助组织公司内部GMP培训、新人质量岗前培训，做好培训记录、考核归档工作。 / Assist in organizing internal GMP training and new staff pre-job training, and archive training records and assessment results.
• 跟进药品质量新规、GMP行业知识学习，协助更新体系合规内容，配合完成年度产品质量回顾、稳定性试验资料整理等工作。 / Keep learning updated pharmaceutical regulations and GMP guidelines, assist in system upgrading, and support annual product quality review and stability study document sorting.

任职资格项Qualifications
学历/专业Education/Majors
本科及以上学历，药学、药物分析、药物制剂、制药工程、中药学、生物制药等医药相关专业。
Bachelor degree or above in Pharmacy, Pharmaceutical Analysis, Pharmaceutics, Pharmaceutical Engineering, Chinese Materia Medica, Biopharmaceutics or related pharmaceutical disciplines;
工作经验要求Working Experience
可接受应届生，有相关药品行业实习经验优先。
Open to fresh graduates with no working experience; prior pharmaceutical internship experience is highly preferred.
知识技能水平Knowledge and Skills
熟悉基础药品法律法规、GMP基础理论、药典常识；具备良好的文字撰写、数据整理、文档归档能力；工作严谨细致、责任心强、服从管理，具备良好的学习能力和团队协作意识。
Familiar with basic pharmaceutical laws and regulations, GMP theories and pharmacopoeia knowledge; proficient in document writing, data sorting and filing; rigorous, responsible, cooperative and self-motivated with strong learning ability.
能力素质要求Competences
熟练使用Office办公软件，具备基础的数据统计与文档排版能力，愿意长期从事医药质量合规工作。 / Proficient in Office software with basic data statistics and document typesetting skills; willing to engage in long-term pharmaceutical quality compliance work.
培训要求Trainings
至少应接受岗位职责以下相关主题的培训列表：
The position responsibilities relevant topics shall be trained as minimum
1、药品法律法规Pharmaceutical laws and regulations and
2、药品GMP体系pharmaceutical GMP system
其他Others
工作严谨细致、积极负责、执行力强，重视质量细节管控，主动排查、跟进并解决基础质量问题，工作务实尽责、不推诿懈怠。 /
Rigorous, meticulous, proactive and responsible with strong execution ability. Focus on quality detail management, take initiative to identify and resolve basic quality issues with a pragmatic and dedicated working attitude.