工作内容：
1.法规的符合性Compliance with regulations
1.1.学习国家药品法律、法规，以指导质量管理工作，保障GMP生产部门的各项工作符合国家相关法规。
Learn national drug laws and regulations to guide quality management and ensure that the work of GMP production department complies with relevant national laws and regulations.
2.厂房、设施、设备Buildings、Facilities、Equipment
2.1.负责GMP厂房、设施设备及其相关记录的日常检查和管理工作，保证其可以正常运行并且满足GMP生产需求。
Responsible for the daily inspection and management of GMP factories, facilities, equipment, and related records to ensure their normal operation and meet GMP production requirements.
2.2.监督纯化水系统的管理，负责对工艺用水的生产进行检查，审核相关记录。
Supervise the management of the purified water system, responsible for inspecting the production of process water and reviewing relevant records.
2.3.监督洁净区空调系统的管理，负责洁净区环境监控的跟踪和相关记录的审核。
Supervise the management of HVAC. Responsible for monitoring the clean area environment and auditing the related records.
2.4.负责害虫控制执行的监督和记录的审核。
Responsible for supervising the implementation of pest control and reviewing the record regularly.
3. 计量器具管理Management of the Measuring Instrument
3.1.负责监督计量器具依据国家法规和相关SOP完成计量器具的年度校准计划，计量器具分类评估。
Responsible for supervising the completion of the annual calibration plan and classification evaluation of measuring instruments in accordance with national regulations and relevant SOPs.
3.2.确保仪器仪表的定期校准工作，签发计量合格标签，确保校准证书在有效期内，将计量证书归档保存。
Ensure periodic calibration of instruments and meters, Issue metrological labels,Ensure the calibration certificate is valid, Certificate of metrological filing.
4.验证管理Validaiton Management
4.1.审核GMP年度验证总计划，监督生产部门验证计划执行情况。
Review the GMP annual validation master plan and supervise the implementation of the validation plan by the production department.
4.2.参与GMP制剂生产部门验证方案、记录和验证报告的审核，在验证完成后进行归档保存。
Participate in the review of GMP DP production department validation plans, records, and validation reports, and archive and preserve them after the validation is completed.
4.3.监督检查在验证实施中的偏差及整改措施。
Supervise and check the implementation of the deviation and corrective measures in validation.
5.物料及供应商管理Material management
5.1. 负责供应商审计工作，收集供应商资质资料、问卷，起草审计报告，维护供应商清单，确保物料的供应商均经过审计和批准。
Responsible for supplier audit, collecting the supplier qualification material, questionnaire, preparing the supplier audit report, maintaining the supplier list,ensure material suppliers are audited and approved.
5.2. 监督物料的入库、储存和出库管理，审核物料管理记录并完成物料的放行, 监督不合格物料管理以及特殊物料管理。
Supervise material entry, storage and exit management, review material management records and complete material release, supervise nonconforming material management and special material management.
5.3. 发放物料代码
Issue the material code.
6. 制剂产品临床标签Clinical Labeling of DP
6.1. 负责标签模板的审核批准，签署 临床标签模板审批表，确保标签内容符合国家法规及相关SOP的要求。
Responsible for the review and approval of the label template, sign the Review and Approval Form of Clinical Label Template, and ensure that the label content conforms to the national regulations and related SOP requirements.
6.2. 负责临床产品标签的订购/打印及检查放行。
Responsible for clinical product label ordering/printing and inspection release.
6.3. 负责QA条码打印机的使用、清洁维护管理。
Responsible for the use, cleaning, maintenance and management of QA barcode printers .
7. 项目管理Project Management
7.1. 审核生产前的主批生产记录及生产后执行批记录。
Review the master batch records and the execution batch records.
7.2. 负责监督产品从物料进入生产工艺之后的生产、包装和发货的全过程。
Responsible for supervising the whole process of production, packaging and delivery of products from the raw material into the production process.
7.3. 负责生产过程中的清场放行检查，物料取样后的清场放行检查。
Responsible for clearance release inspection during production process and clearance release inspection after material sampling
7.4. 负责项目清洁确认的审核批准，配合相关部门进行清洁确认工作, 放行已清洁合格的设备。
Responsible for the reviewing and approval of the project cleaning verification, and cooperate with relevant departments for cleaning verification, release clean and qualified equipment.
8. 负责监督制剂生产部门使用记录的发放和回收。
Responsible for supervising the release and recovery of the use records of the DP production department.
9. 参与工作相关的偏差、变更控制、投诉等质量事件的调查。
Participate in the investigation of work-related deviations, change control, complaints and other quality incidents.
10. 参与GMP制剂车间、设备间及库房的日常巡检工作。
Participate in the routine inspection of GMP DP workshop, equipment room and warehouse.
11. 完成本部门领导临时安排的工作。
Complete other tasks arrangements by department head.

教育背景及任职资格
1.教育背景：化学、应用化学、药学或相关专业本科或大专及以上学历
Education Background：Bachelor degree or college degree above in chemistry, applied chemistry, pharmacy or other related fields.
2.经验：应当至少具有药学或相关专业本科或大专学历（或中级专业技术职称或执业药师资格）。本科学历，具有至少1年从事药品生产和质量管理的实践经验，接受过与所生产产品相关的专业知识培训。大专学历（或中级专业技术职称或执业药师资格），具有至少2年从事药品生产和质量管理的实践经验，接受过与所生产产品相关的专业知识培训。
Experience: A bachelor degree or college degree above in pharmacy other related field(or qualified midlevel with the title in professional or licensed pharmacist ), bachelor degree ,more than 1 years of experience in drug production and quality management, trained in professional knowledge related to the products produce. college degree (or qualified midlevel with the title in professional or licensed pharmacist ), more than 2 years of experience in drug production and quality management, trained in professional knowledge related to the products produce.
3 技能技巧：具有一定的专业英语读写能力。
Skills: have a certain ability to read and write in professional English.