罗氏促进多元化、公平性和包容性，代表我们所服务的社区。在全球范围内处理医疗保健问题时，多元化是成功的关键因素。我们认为，包容性是理解人们不同医疗保健需求的关键。我们共同拥抱个性，共同抱持对卓越护理的热情。加入罗氏，每个声音都会得到重视。 职位 Principle Roles & Responsibilities / Accountabilities: GMP Training Management/GMP * Act as GMP training process as well as learning business process owner, develop GMP training system and procedures to ensure the training effectiveness of employees who perform GMP activities to meet Roche quality system and health authority (China/EMA/FDA) requirements. * Maintain and optimize the GMP training system to improve employees' understanding of GMP, regulations and other requirements. * Develop and implement annual GMP Training Plan in site. * Review and Approve of training material, training plan, and job description. * Support in learning system maintenance and contact with Global Learning Services (GLS) to maintain training data timely and accurately. * Site contact person with global learning network. GMP document and record management/GMP * As GMP document and record management process as well as business pricess owner, maintain and improve GMP document and record management process at site, and ensure its compliance with applicable laws and regulations. * Oversee the site GMP document and record retention and destruction. * GMP documents and records compliance review and approval. * Site contact person with global GMP document management network. * Site contact person with external file service provider. Site Master File * Act as the Site Master File business process owner, maintain and manage Site Master File. * Update site master file with related departments periodically as required. * Ensure that the site master file and its related processes are consistent with regulations and Roche global PQS requirements. Management Review of Quality and Quality Metrics * Support Management Review of Quality and provide quality metrics reporting and data analysis as site required. Others * Support and coordinate the implementation of new issued regulations. * Support the monitoring of the new issued regulations implementation. * Support and participate external and internal inspection/audit. * Other activities assigned by line manager. Qualification and Experience Education/Qualifications * Bachelor Degree or above (or with an intermediate professional technique certificate or a pharmacist’s license). * Pharmacy, Chemistry, Biochemistry and equivalent preferred. * At least 3-5 years’ experience in Quality Unit or Production of scaled or joint venture Pharma Company. Leadership Competencies * Models Integrity * Focus on value and customer * Align for success * Deliver results * Learn for the future Job Required Competencies * Good accountability of GMP understanding and implementing. * Good knowledge of Quality System principles, practices and standards for the pharmaceutical industry. * Knowledge and experience in production and quality management. * Manage oneself/demonstrate lead ship within own role. * Well communication skill and good accountability of problem solving. * Good at English, listening, speaking, reading and writing. * Good at office software: Word, Excel, Power Point. 我们是谁 在罗氏，来自100个国家的100，000名员工不断推动着健康医疗行业的进步。我们一同工作，使罗氏成为了世界领先的以研发为基础的健康医疗集团。我们的成功源于创新、求知和多元化，也源于我们把相互间的差异作为一种优势。为了革新医疗健康领域，罗氏设定了远大的计划，坚持学习和发展，并不断寻找与之志同道合的伙伴。 罗氏中国由制药和诊断两大业务领域组成，员工总数超过7000人。作为全球个体化医疗的领导者，罗氏制药和罗氏诊断均在中国建成了完整的价值产业链，包括研究、开发、生产、营销等环节。未来，上海将成为罗氏继巴塞尔和旧金山之后的第三大全球战略中心，而罗氏也将继续践行对中国的长期承诺，满足中国患者的未尽之需。 罗氏提供平等的职业发展机会。
