北京招聘

Job Responsibility:

Site GMP & Compliance Training Management 工厂GMP和合规性培训管理

• Create and maintain Site Master GMP Training Procedure.

更新和维护工厂GMP培训主程序。

·Collect training needs and integrate internal or external resources to make annual GMP training plan. Define trainers and trainees of these trainings. Support trainers to develop training materials if necessary. Assess the quality of the trainings.

收集培训需求，整合内外部资源来制定GMP培训计划。确定讲师和学员。若必要，协助讲师创建培训教材。评估年度GMP培训的质量。

• Roll out and follow up the global GMP trainings, including defining trainers and trainees, collecting Training Summary Sheet and certificates. Statistic completion rate and report the result.

开展并跟踪总部GMP培训，确定培训讲师及学员，收集培训信息汇总表和证书，以及统计培训完成率。

• Statistic GMP trainings data monthly. Integrate and analysis data by the end of the year. Retain the training materials, plan, records, summary sheet etc. in a secure location and arrange them periodically

• 每个月统计各部门GMP培训数据，年底进行整合及分析, 将培训资料，计划，记录，汇总表等培训文件保存在安全的地方并定期整理。

• According to GMP & working requirement, arrange inspection training, re-training and the training of visitors & CMO.
• 根据GMP法规和工作要求，安排检查性培训，再培训以及对来访者和承包商的培训。

• Introduce the training system and procedure, and provide documents when auditors come.

• 检查者来访时负责介绍培训系统和流程，并提供相关的培训文档。

• Deploy GMP training documentation spot-check. Report the result to relevant managers and supervise staff to revise them.

  开展GMP培训文档抽样检查，将结果报告给相关管理人员并监督员工改善。

• According to the implementation plan of PQS documents to follow up the PQS training. Coordinate with local SMEs, global training coordinators to translate PQS training materials.

  根据PQS文件执行计划来跟踪PQS培训。与当地主题专家和总部培训协调员进行沟通来翻译PQS培训材料。

  Non GMP training

  非GMP培训

• Support to develop and maintain a satisfactory training system to ensure qualified employees in PT Shanghai to carry out all the tasks in the job description.

  协助建立并维护适当的培训体系，确保技术运营部所有人员都经过与岗位要求相适应的培训。

• Assess and Define requirements: Identify knowledge and skills necessary to qualify personnel to perform task based on job role and level of responsibility.

  评估并确定需求：根据工作职责和责任级别确认开展相关人员所需的知识和技能。

• Making comprehensive annual training plan, coordinate and organize the training as well make corresponding statistic according to global or site requirements

• 根据总部或本地的要求，制定和协调技术部年度的综合培训计划，协调、组织综合培训，并做相关统计

• Create training: Oversee the trainer to design course objectives, learning method, content structure and supervise the author make training materials.

• 创建培训：监督培训老师来设计课程目的，学习方法，内容架构，并监督作者来制作培训资料。

• Execute training: Support to Plan, deploy and conduct training with trainers and trainees.

  实施培训：协助与培训老师和学员一起计划，开展培训。

• Retain the training materials, plan, records, summary sheet etc. in a secure location and arrange them periodically

  将培训资料，计划，记录，汇总表等培训文件保存在安全的地方并定期整理。

• Evaluate training effectiveness: Organization the assessment of training materials to enable qualification and of personnel to demonstrate qualification

• 评估培训效果：组织对培训材料是否能达到目标的评估，以及培训学员经培训后是否合格的评估。

Reuqirements:

Education/Qualifications教育程度/所获资格证书

Bachelor degree holder (equivalent) or above

学士学位或以上

Graduate from management or medicine subject

管理或医药相关专业

Leadership Competencies领导者胜任力

Good communication skill

良好的沟通能力

Good team work skill

良好的团队合作能力

Job Required Competencies岗位所需胜任力

Fluent reading/writing/Oral English

流利的英语读写说

Skillful about Microsoft Office Software

熟练使用微软办公软件

Around two years experience of GMP training will be preferred.

有2 年左右GMP培训相关经验的优先。

上海罗氏制药有限公司成立于1994年，是抗肿瘤、抗病毒、移植等关键领域的市场领导者。在大型跨国药企中，我们率先在中国建成了包括研究、开发、生产、营销等环节在内的完整的医药价值产业链。罗氏中国正向着成为罗氏全球第三个战略中心的目标迈进，以实际行动践行在中国长期发展的承诺。

我们始终以患者为中心，致力于帮助患者从根本上延长生命和改善生活质量。目前，罗氏在华拥有16个产品，覆盖8个治疗领域。我们与政府、医疗机构以及非政府组织等社会各界多方携手，共同探索创新的合作模式，通过一系列有影响力和可持续的举措惠及更多的中国患者。

更多罗氏中国信息，请登陆罗氏官网或访问罗氏招聘公众号。