锦鲤求职岗位描述
岗位职责：
Job Responsibility
1、 对原液和/或制剂生产全过程实施现场质量监督，对关键生产操作进行现场确认，确保严格按照已批准的工艺规程（MBR/BPR）、标准操作规程（SOP）执行生产活动，保证所制定的各项操作规程符合GMP要求并贯彻执行，以保证药品产品质量。
Provide on-the-floor quality oversight throughout the entire drug substance and/or drug product manufacturing process. Perform real-time verification of critical manufacturing operations to ensure activities are carried out in strict compliance with approved Master Batch Records (MBR/BPR) and Standard Operating Procedures (SOPs). Ensure that all operational procedures comply with GMP requirements and are effectively implemented to maintain product quality.
2、 负责审核批生产记录，审核关键工艺参数执行情况，审核环境监测结果，审核偏差及变更影响评估，为产品放行提供质量决策支持。
Review batch production records, verify compliance with critical process parameters, assess environmental monitoring results, and evaluate the quality impact of deviations and change controls. Provide quality oversight and decision-making support for product disposition and batch release.
3、 无菌工艺、关键公用系统与物料的污染风险识别，主导异常事件调查；
Identify contamination risks associated with aseptic processes, critical utilities, and materials, and lead investigations of deviations, excursions, and other atypical events to determine root causes and implement effective corrective and preventive actions (CAPA).
4、 牵头组织跨职能团队编制覆盖全生命周期的CCS文件，明确所有关键控制点；监督污染控制策略在生产现场的实施情况；
Lead cross-functional teams in developing and maintaining a lifecycle-based Contamination Control Strategy (CCS), ensuring that all critical control points are clearly defined. Oversee the implementation and effectiveness of the CCS within manufacturing operations to minimize contamination risks and maintain a state of control.
5、 负责及时发现生产线在线问题并及时上报，并对生产或产品做出紧急处理建议，确保潜在问题产品可控，不会流入下道工序。
Responsible for timely identify the online problem, give immediately disposition suggestion, ensure the issue product under control in a timely manner when it presents, to ensure it would not be in the next process.
6、 负责生产区域功能间的清理和清场的检查和放行。负责生产车间设备的放行工作。
Responsible for inspection and release of clearance and changeover in function rooms in manufacturing area; responsible for equipment release in manufacturing area.
7、 参与工厂偏差、变更及投诉等调查、影响评估，参与CAPA制定及有效性确认并审核调查报告。
Participate in site deviation, change and complaint investigation and perform impact assessment, participate in CAPA initiation and effectiveness check and review investigation report.
8、 负责批生产记录的受控发放和回收。
Responsible for controlled distribution and recovery of BPRs.
9、 参与技术转移，审核新产品引入相关文件。
Involved in the technical transfer process, review new product introduction related documents.
10、 参与工艺验证、持续工艺确认及工艺优化相关的活动，审核相关的文件。
Involved in process validation, continuous process verification and process optimization related activities, review related documents.
11、 参与年度产品质量回顾相关工作。
Participate in annual product quality review.
12、 作为审计支持人员参与质量审计工作的准备，如资料的收集及审核等。
Responsible to support quality audit readiness, e.g. supporting document collection and review.
13、 遵守公司的规章制度，遵守保密制度，坚持保密原则。
Obey the regulations of company, obey the confidential regulation and insist the confidential principle.
14、 完成上级交办的其他工作。
Finish the other jobs assigned by the supervisor.
教育程度/经验：
Education/Experiences
1. 本科及以上学历，生物制药相关专业；
Bachelor degree above, biopharmaceutical major;
2. 8年以上药品或生物制药QA的工作经验；
At least 8 years of pharmaceutical QA working experience.
技能要求：
Skills
1. 良好的英语读写能力。
Well verse in reading and written English.
2. 熟练的使用计算机办公软件。
Skillful in using computer software.
3. 有良好的沟通技巧，工作认真、细致，具有良好的团队合作精神。
Good communication skill, attentive, careful and meticulous, with strong team-work ability.
4. 熟悉欧盟、中国和美国GMP法规相关要求。
Familiar with GMP regulations and requirements of EU, CFDA, and FDA.