Lead Specialist-QA Shift
作为翻班QA现场支持人员, 他/她负责处理所在生产区域的日常问题，如有需要及时反馈给区域QA人员。并执行生产过程的现场质量监管，确保整个生产过程和产品质量得到控制并符合所有适用的标准要求
He / She is responsible for ensuring that daily problems of the area are promptly addressed as the shift QA function support, and if necessary, escalate to the area QA. He / She will perform on site quality oversight for manufacturing process and ensure all process and product quality are in control and complaint to all applicable standard requirements.
安全
Safety:
61 作为安全小组成员；参加安全小组检查和安全巡检。
Be part of the safety team; participate in safety cell tours & safety walkthroughs.
61 *遵守HSE各项管理流程，履行安全生产职责要求。
Follow various HSE management procedures and fulfil the work safety responsibilities.
质量
Quality:
61 应具有与质量及其所在领域（EM，无菌制造等）相关的GQS和CQP的工作知识。
Should have working knowledge of GQS and CQP expectations related to Quality and the activities within their area (EM, Parenteral manufacturing.... etc.)
61 在一线生产活动期间80％的时间保持在生产线上。进行轮班检查和审计。对B4和B5发现的质量巡检发现项进行后续行动。进行生产线连续性质量检查（每班2-3次），以备审核；抽检在轮班中执行的PMX工单。
Maintain presence on the floor 80% of the time during production activities. Perform shift floor checks & audits. Follow-up for Quality Walk-through observations in their shift with B5 and B4s. On-floor quality checks (2-3 times per shift) review to be continuously audit ready; Spot-check PMX tickets performed in their shift.
工艺
Process:
61 在其范围内应具有操作方面的工作知识。他们应该密切了解操作流程以及他们所在区域的活动执行方式，以及发生的历史偏差/事件，更好地支持运营以减轻即将发生的事件并在上报时做出适当的决定。
Should have working knowledge of the operations within their scope. They should be intimately aware of the working procedures and how activities are executed in their area and historical deviations/issues that occurred to better support operations in mitigating future issues and making the appropriate decision when to escalate.
61 在流程团队中进行确认之前，当班QA与偏差发现项作者开启偏差发现项，复核偏差的内容以确保措辞的合理性（***程度地减少了工艺团队修改偏差发现项的工作量）。提供有关立即采取措施以减少质量影响的指导。
Open deviation observations for events occurring in their shift, reviewing deviation content with the deviation observation author prior to triage in the process team to ensure consistency in wording (minimize the effort for the PT to rework the deviation observation). Provide guidance on the immediate measures taken to reduce quality impact.
61 从生产一线收集有关事件影响范围内的有关根本原因分析的初始信息。
Collects initial data for RCI from the floor with regards to boundaries of the event.
61 管理HOLD申请和最终批准，批准工单并在当班期间释放设备及区域，并移除hold状态。在需要时恢复生产；审核RTS和MAP执行。审核恢复计划的执行。
Manage HOLD application and final approve, approve work orders and release to service of equipment and areas during their shift and remove hold status. Resume production when it’s needed; Review Return to Service and MAP execution. Review execution of recovery plans.
61 作为关键报警的质量联系人以确认并预先批准关键行动；在执行过程中审核PMX日志和HMI / AAMS关键报警，若发现异常趋势，上报到工艺团队。
Be the *** QA contact for critical alarms acknowledge and pre-approval critical actions; Review PMX Logs and HMI/AAMS critical alarms during execution and escalate to primary loop for abnormal trends.
61 查看PMX日志并收集信息以进行批审核，包括FIT和DART报告；批准在一线生成的报告（DART）并管理GMP库中的文档保留。
Review PMX logs and collect information for batch review, including FIT & DART reports; approve generated reports on floor (DART) and manage documentation retention in GMP library.
61 参与工艺前提条件检查。
Participate in process start gate review.
61 介入现场以了解工艺质量或性能损失的原因；
Intervene in the field to understand the causes of quality or performance loss of the process;
61 支持工艺数据的收集和趋势分析，以防止不符合项或偏离。进行实时过程监控和批次表现数据审查。
Support the collection and trending of the process data to prevent non-compliance or discrepancy. Conduct real time process monitoring and batch performance data review.
部门
Function:
61 支持由于工艺问题引起的不符合项的调查，包括开启偏差发现项，参与故障排除，执行纠正和/或预防措施。支持关键报警的报警响应，包括QBMS报警和调查。
Support the investigation for the non-conformities ascribable to process problems, including opening deviation observation, participating on troubleshooting, executing corrective and/or preventive actions. Support alarm response for critical alarms including QBMS alarms and investigation.
61 完成半成品物料批释放（消毒剂/硅油/酸/碱/限制性使用）；审核半成品物料批记录。
Batch release of intermediate materials (Sanitizing/silicon/acid/ base/ restricted use); Review intermediate material batch records.
61 至少要在轮班报告中记录以下内容：偏差发现项，HOLD，半成品物料的释放，RTS状态。
Document at minimum the following in the shift report: Deviation Observations, Hold, Release of intermediate material, RTS status.
61 审查/复核IPC和实验室检测样品并移交给实验室。
Review/verify IPC and lab release samples and handover to labs.
61 审核预批准的质量关键动作，非编码的干预措施，B级区个人取样，AAMS访问和一线物料转移。
Review pre-approved quality critical actions, non-coded interventions, personnel grade B sampling, AAMS access and material transfer on the floor.
61 在Media Fill期间有资质担任QA观察员。
Qualified as QA observer for Media Fills.
61 创建或审查与生产相关SOP / WI；参加HEP调查以防止人为错误。
Create or review SOPs / WIs relating to shop floor; Participate in HEP investigations to prevent human errors.
61 合作调查市场上的投诉；
Collaborate in investigations of complaints from the market;
61 定期与TSMS审查IPC数据并管理样品和交付。
Review IPC data with TSMS routinely & manage samples and delivery.
跨部门
Cross function:
61 向工艺和/或系统提供任何可能的改进，包括与生产经理主导PVP活动以及跟踪改进行动直至完成。
Provide any possible improvement of processes and/or systems, including practice versus procedure activities to the Ops Manager and tracking improvement actions to closure.
61 对zero loop和一线员工就质量体系要求（SPV QP，质量流程，DI，合规性更新）进行教育，指导和不断强化。
Educating, coaching and ongoing reinforcement to the zero loop and the front-line staff on the quality system requirements (SPV QP, Quality procedures, DI, Compliance Updates).
61 作为zero loop和primary loop QA之间的协调员。
Serve as coordinator between the floor zero loop and primary loop QA.
61 担任实时协调员以解决生产一线出现的的物料事件。
Serve as real-time coordinator to resolve material issues on the floor.
基本要求:
61 遵守所有安全政策，标准和准则。
Adherence to all the safety policies, standards and guidelines.
61 熟悉GMP等相关法规要求，具有良好的GMP意识。
Be familiar with GMP and relevant regulatory requirements and have good GMP sense.
61 支持一线日常生产的时间应占80%以上。
Minimum 80% of time at shop floor to support daily operations.
61 如需要，报告问题至当班生产经理。
Escalate problems to the OPS manager on shift if necessary.
61 大专及以上学历，药学化学或相关学科专业。
College degree or above, majored in pharmaceuticals, chemistry, biology, engineering or related sciences.
61 在QA，QC，生产，工程，技术或法规有相关工作经验者优先。
Experience in QA, QC, Production, Engineering, Technical Services, or Regulatory is desirable.
61 熟悉中国法规者优先。
Familiar with Chinese regulation is preferred.
61 英语读写能力佳者优先。
Be capable of reading and writing in English is preferred.
其他信息:
61 工作于胰岛素笔芯无菌生产工厂的各个区域。
Work in various areas within the Insulin Cartridge Parenteral Plant.
61 能够根据要求适当加班。
Ability to work overtime as required.
61 翻班需求（有夜班）。
Shift work required.