岗位职责和要求
Key responsibilities主要职责：
1.Be accountable for the environment hygiene safety and quality issues in position as well as subordinates (if available) and equipment performance.
对本岗位职责范围内的环境卫生安全和质量负责，并对下属(如果有)的工作质量和环境安全和设备运行情况负有责任。
2. Maintain and implement the best, surest and easiest work processes. Initiate, participate and facilitate the continuous improvement activities on safety, quality, cost, delivery, motivation and environment by applying DaMaWay (including LEAN principles etc).
维护并实施最好、最可靠、最简单的工作流程；应用DaMaWay (包括精益原理等)，在安全、质量、成本、交付、激励和环境方面,发起、参与并推动持续改进活动。
Safety 安全
1.Use the WISE methodology to develop a zero risk operating culture and environment, guarantee a safe environment
用WISE的方法，创造一个0风险的生产文化和环境，确保安全。
2. Accountable for the environmental,health, safety and quality within the scope of position, and responsible for work quality and environmental safety of the team.
对本岗位职责范围内的环境卫生安全和质量负责，并对所属团队的工作质量和环境安全负有责任。
System & quality compliance体系和质量符合性
1. Control production conditions, environment, sanitation, facilities, etc., to ensure all production activities comply with GMP/ISO and followed by processing and procedure requirment, focus RFT so only qualified products can be released to the next process to ensure product superiority.
管控生产条件、环境、卫生、设施等,确保所有生产活动符合GMP/ISO并按相应工艺及公司相关程序进行，确保正常产品才能放行到下一道工序，确保一次合格率，实现产品高质量。
2. Ensure the validations of the production process, equipment, cleaning etc.
确保工艺、设备、清洗等验证工作按要求执行。
3. Organize the investigation and analysis of deviation and complaint; secure the implementation of CAPA actions related to production.
组织生产中所有偏差及生产相关的投诉问题的调查与分析，确保生产相关的纠正措施和预防措施的及时落实及有效性。
4. Develop necessary SOPs and ensure the implementation and drive the improvement on quality.
组织制定相关的岗位操作规程并确保执行, 推动质量的持继改进。
5.Secure GMP and relevant requirements are fully followed, such as:
确保能遵守GMP相关条款并落实，例如：
5.1Manufacture and storage the pharmaceutical goods according to approved technology procedure in order to ensure the quality.
确保药品按照批准的工艺规程生产、贮存，以保证药品质量；
5.2. Ensure every operation procedures related to production acitivities are performed strictly;
确保严格执行与生产操作相关的各种操作规程；
5.3. Ensure batch production record （include batch package record ，and CCP and OPRP confirmation rocord） are audited and signatured by self or by designated person and submitted to quality management department
确保批生产记录(包括批包装记录,CCP 和OPRP确认记录)经过自己或指定人员审核并签字并送交质量管理部门；
'- Attend FSHCP team meeing
- Establish, verification and implement FSHCP
- Ensure the effective of FSHCP
- Implement FSHCP internal audit
- Review deviations of critical limits
- Establish and maintain FSHCP documents and meeting minutes
- Communicating the implementation of FSHCP
-参加FSHCP小组会议
-建立和实施FSHCP计划，并进行验证和确认
-确保FSHCP计划有效运行
-实施FSHCP内审
-回顾关键限值的偏差
-建立和维护FSHCP P文件和会议纪要
-交流FSHCP计划的执行情况
CIP & production process HACCP analysis, FSHCP data collection (flowchart, process description, product description,etc...), implementation, operator training, on-site visualization management
CIP工艺流程和生产过程FSHCP分析、信息收集（流程图、过程描述、产品描述等、现场实施及操作员培训、可视化管理工作
5.4. Cooperate with service department to ensure prodciton premises and equipemt are properly maintened in good working condition确保完成厂房和设备的维护保养，以保持其良好的运行状态
5.5. Ensure necessary validation work on time in full.
确保配合完成各种必要的验证工作；
5.6. Plan necessary resource to ensure proper training to the team beofre on-boarding and keep training content updated according to actual demands.
确保生产相关人员经过必要的上岗前培训和继续培训，并根据实际需要调整培训内容；
5.7 Supervise the sanitation condition of prouction area.
监督生产区卫生状况；
5.8 Supervise the full implemention of GMP regulation
监督GMP规范执行状况；
5.9 Monitor and analyse quality control factors.
监控影响产品质量的因素.
5.10 Ensure FSHCP plan execution(such as CCP & OPRP front line monitor and management and confirmation)
确保FSHCP计划在现场的执行（如CCP和OPRP在现场的监控、管理和确认）。
6.To take the responsibility delegated by associate director for the production batch record review and management.
授权于制造部批生产记录的审阅和管理。
Project, process，excellence & cost 项目、工艺、精益管理和成本
2. Maintain and implement the best, surest and easiest work processes. Initiate, participate and facilitate the continuous improvement activities on safety, quality, cost, delivery, motivation and environment by applying DaMaWay (including LEAN principles etc).
维护并实施管辖区域内最好、最可靠、最简单的工作流程；应用DaMaWay (包括精益原理等)，在安全、质量、成本、交付、激励和环境方面,发起、参与并推动持续改进活动。
2. In charge of the regular validations for product, process, cleaning etc. Participate/lead equipment, new product, new PM/AM validation, drive process improvement proactively.
负责产品、工艺、清洗等定期验证的实施，负责/参与设备、新品、新原料包材的验证工作，积极推动生产工艺的改善。
3.Contribute on new product, new material, new package transfer project. Be responsible for/support the line process control or validation during transferring.
参与研发或OPP向生产转移新产品、新原料、新包装材料工作，负责/协助转移过程中的生产工艺控制或验证工作。
4.Initiate OE / yield losses etc analysis to drive Operation Efficiency and material efficiency improvement continuously.
对效率、收效等进行及时分析，推动运营效率（OE）和收率等技经指标不断提高。
Volume attainment 产量任务的达成
1. Communicate and confirm production scheduling with planning team. Support on Capacity planing and development, contribute and execute Factory Strategic Choices & Masterplan.
与计划团队密切沟通，确认生产作业计划；协助产能规划发展，参与并实施工厂战略决策与计划
2. Organize daily production meeting, coordinate all shifts and keep closely communication with planning, QA, maintenance and warehouse ect, to implement production plan strictly and ensure right Plant Service Level and Bias.
组织每日的生产协调会，协调各生产班组的活动及与质量、计划、维修、仓库间的沟通, 严格执行生产计划，确保生产计划完成率及生产计划符合性。
Maintenance ensurance 维修保证
1.Accountable for emergency maintenance management of the equipment in the managed area, ensure the equipment is in normal conditions during operation.
负责管辖区域内设备的应急维修管理，确保设备在正常状态下进行生产运行。
2.Accountable for the continuous implementing TPM in the area.
负责区域内TPM的持续推进。
Talent and team development 人员发展与团队建设
1.Communicate with HR for people management (operator interview，hiring and arrangement) to ensure right production recourse.
与HR保持沟通，负责生产操作工的资源管理。
2. Ensure that the production staff receive the necessary training and continue to improve the training。
确保生产操作人员按需要进行必要的培训，并不断改进培训工作。
3. Motivate people according to CODE and Proximity Management principles; use PDR/IDP etc to develop talent.
用CODE与亲近管理原则激励团队，通过PDR、IDP等发展人才。确保一线员工激励体系的建立与公平、有效实施。
Others 其它
1. Other tasks temporarily assigned.
临时交办的的其他工作任务。
2. To take the responsibility delegated by associate director when needed; production supervisor/Sr. Process engineer will take the responsibility when absence.
在需要时，承担被授权的职责；当本人不在岗时，授权生产主管/高级工艺工程师负责生产活动的正常进行。
Education & working experience 学历与工作经验要求：
1. Shall at least have pharmacology or related specialty undergraduate education background (or secondary professional technical title or licensed pharmacist qualification)
药学或相关专业本科以上学历（或执业药师资格）
2. At least 5+ years pharmaceutical or food manufacturing and quality management experience, including at least three years pharmaceutical manufacturing/quality management experience, have taken part in professional knowledge training related to manufacturing products.
具有至少五年以上从事药品和质量管理的实践经验，其中至少有三年的药品生产管理或质量管理经验，接受过与所生产产品相关的专业知识培训。
Occupational qualifications职业资格要求：
1.Fluent English
英语流利
2.Familiar with the standard for quality system, e.g. GMP,ISO 9001/22000/14001
熟悉质量体系标准，如GMP, ISO 9001/22000/14001
3.Excellent MS office skills
能够熟练使用办公软件
Others其他：
1.Good communication ，emotion control and analytical skills
良好的沟通，情绪管理以及分析能力
2.Self-motivation and be able to assume working pressure
工作主动，能承担压力 3.High degree of accuracy, have a strong sense of responsibility. Sensitive and careful with data
做事细心，工作负责，对数据敏感
