AstraZeneca Pharmaceuticals LP Packing Process Engineer in Taizhou, China

· 理解业务活动中涉及GMP的相关内容及可能对产品质量产生的影响 Understand the impacts of daily work on GMP requirements and product quality

· 参加GMP相关培训,确保业务活动持续符合GMP要求 Attend GMP trainings and ensure that daily work is compliant to GMP consistently

· 严格执行本岗位的GMP相关规程 Strictly follow GMP SOPs.

· 向直线经理或QA沟通工作中遇到的GMP相关问题 Report to line manager or QA about GMP questions encountered in daily work

GMP 要求符合性

Compliance of GMP requirements

确保业务活动的法规符合性

Ensure regulatory compliance of daily work

法规符合性Regulatory Compliance

· 参与TORA并主持包装工艺讨论过程。

Attendance of TORA and leading the packaging process discussion.

· 负责包装线及其相关组件的验证工作。

Responsible for validation if the Packaging lines all associated equipment parts

· 为接收基地方准备TT相关的技术转移文件,并进行主要相关转移工作。

Preparation of the Technical Transfer documentation and key deliver of all receiving site activities to ensure successfully TT achieved.

工艺设备能按照项目计划适时放行,在GMP检查中无重大工艺验证发现。

Process equipments can be released on project schedule, and no major findings on process validation in GMP inspection

按照项目计划成功向泰州基地转移产品。

Products successfully transferred to Taizhou site in line with Project plan.

· 遵循质量管理系统的实施流程包括清洁验证策略,建立并维护包装验证规程。

To establish the packing validation procedures to align with Quality Management System go-live schedule. Inclusive of cleaning validation strategy

· 管理新包装物料组件的验证工作,确保规格符合全球标准。

Manage the validation of new packaging material component and ensure that the specifications are in line with global standards

应按照质量规定的时间/要求建立并维护SOP。

The SOP shall be established and maintained with Quality timeline/requirement/

按照SAP项目时间建立并维护BOM

Establishment and maintenance of the BOM with SAP project timeline.

符合SAP主数据变化管理要求。

Compliance to the SAP master data change management requirement.

· 包装物料 – 联系物料供应商,确保获取质量标准及时间安排计划。

Packaging material - Contact with Material supplier to ensure the quality criteria and timeline are provided .

· 与中国MC及MCAN保持联络,确保所有设计工作已更新并符合要求。

Liaise with China MC and MCAM to ensure all artwork is up to date and compliant

· 与Schwark(第三方)保持联络,确保设计图纸在项目计划时间内按时完成。

Liaise with Schwark (3rd party) to ensure artwork is generated on time to meet Project timelines

· 与泰州内各职能部门协调,确保新旧Artwork设计图纸替换的正确处理。

Communication with internal functions at Taizhou to ensure that the cutover from old to new artwork is effectively managed.

物料没有潜在质量问题。

No quality issue shall be foreseen in the material.

Artwork RFT 100%。

Artwork RFT 100%

确保泰州包装符合全球产品安全及防伪制定的相关要求。

Ensure that Taizhou packaging is compliant with the global product security and anti counterfeit requirements as specified with the Global Team

生产及质量团队。

Operation team and Quality Team

作为阿斯利康泰州供应基地的一名员工,每一位员工对其本人与他人的业务行为、健康与安全、环境保护、帮助公司持续改进绩效和声誉负有相应的责任。因此,每一位员工必须:

As an employee in Taizhou Supply Site, everyone should be responsible for health and safe、environment protection of him/herself and colleagues, assist company to continually improve the performance and reputation. According to this, every employee should:

· 理解其业务活动中涉及安全、健康及环境的相关内容以及该活动可能对整个公司的安全、健康环境绩效产生的影响。

Understand the business activities related to the content of safety、health and environment, and the appropriate effects to the entire company’s safety, health and environment.

· 参加培训并提出必要的培训需求,确保其业务活动的安全、合法,保护环境。

Attending the training and raise necessary training requirements, ensure the safety, compliance of the business activities, and the protection of environment.

· 持续表现符合政策的安全、健康与环境行为,并通过交流与沟通,持续改善安全、健康与环境的绩效。

Continually demonstrate the behavior corresponding with policy of safety, health and environment, also continually improve the performance of safety, health and environment through interpersonal communication.

· 严格执行本岗位的安全操作规程,并按要求正确使用劳动防护用品,拒绝违章指挥,切实做到“四不伤害”,即不伤害自己,不伤害别人,不被别人伤害,保护别人不受伤害;

Strictly follow the job’s safety operation process, and use articles for labor protection correctly, refuse commanding against rules, achieve the goal of “No Hurts FOUR”, neither hurt oneself, nor hurt others, do not be hurt by others, and prevent others to be hurt;

· 可以向您的直接经理或通过行为准则帮助热线就您工作中遇到的安全、健康与环境的有关问题及建议、他人的相关表现以及公司的安全、健康环境绩效进行沟通。

You can report to your line manager or use the hotline of code of conduct to communicate with the encountered safety, health and environment issues, also company’s safety, healthy environment performance can be communicated.

· 采取积极的、正确的态度真实地、准确地填写有关安全、健康与环境绩效的记录以及相关文件,并进行汇总、提交、保存,这有利于公司对所设定目标的进展进行准确地评估,并将评估信息与相关方或其他相关人员进行分享。

Adopt the positive, right attitude to fill in related documents about safety, health and environment performance correctly, summarize, submit and save them. These activities will help to evaluated company’s goal accurately, and it will also be shared with interested parties or other related people.

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