岗位职责 Job Responsibilities
在QA经理的领导下，负责实验室系统的质量管理。确保体系和运作符合现行GMP 要求，包括但不限于实验室文件和记录的审核，数据可靠性管理，实验室异常事件调查审核以及其他GMP 活动。
61 Responsible for the quality management of QC under the leadership of QA Manager. Ensure that quality systems and operations comply with current GMP requirements, including but not limited to the review of QC documents and records, data integrity management, QC anomaly investigation and review, and other GMP activities.
61 负责分析方法验证/确认/转移方案和报告的确认与审核。负责实验室仪器验证/确认方案和报告的确认与审核。负责质量标准、取样方法/计划、检验方法和其他QC质量管理操作规程的审核；实验室检验记录及其他管理记录审核;
Responsible for the analytical methods validation/verification/transfer protocols and reports review. Responsible for the laboratory instruments validation/verification protocols and reports review. Responsible for the review of specification, sampling methods/plan, test methods and other QC SMP and SOP; QC test records and other management records review;
61 参与实验室可疑数据、偏差的调查及报告审核；参与实验室相关变更、CAPA、风险评估的审核；
Participate in OOS, deviation investigation and report review; Participate in QC related changes, CAPA, risk assessment review;
61 参与实验室系统回顾并且确保系统回顾按时完成；
Participate in QC system review and ensure that the system review is completed on time;
61 参与实验室相关数据可靠性及资质培训改善项目；支持培训协调员的工作；
Participate in QC data reliability management and qualification training improvement project; Support training coordinator
61 参与实验室改善项目；执行实验室的日常巡检；参与实验室相关的自检，支持外部审计；
Participate in QC improvement projects; Performs QC routine inspection; Participate in QC related self-inspection and support external audit;
61 上级领导安排的其他事项。
Other duties as assigned by line manager

技能要求Required Skills
61 大学本科以上学历，药学、化学、生物学或相关专业。
At least university degree, major in pharmaceutical, chemistry, biology or related subjects.
61 至少5年医药行业QA 或 QC经验。
Minimum 5 years of QC for QC working experience in pharmaceutical industry.
其中至少2年以上QC工作经验At least 2 years of experience in QC (Quality Control).
61 期望有质量控制工作经验。
Experience in Quality control is preferred.
61 良好的沟通、解决问题、计划和组织能力。
Excellent communication