上海招聘

Core mission

·         Lead and manage activities related to Quality Assurance

·         Maintain the local Quality Management System and monitor its compliance status

·         Contribute proactively as an effective leader, functioning responsibly and autonomously while working within the framework of internal and external regulatory guidelines and procedures.

Main responsibilities

·         Responsible for ensuring Good Distribution Practice (GDP) is complied with for products imported and wholesaled 

·         Perform Quality and compliance specific tasks including but not limited to processing product complaints, review of information about secondary packaging/redressing, ensure proper labelling of products at the distributor, and product recall coordination.

·         Participate in the creation/update of local SOPs to reflect local practices in accordance with Corporate Policies and SOPs

·         Implementing and maintaining the QMS to ensure that required processes are established and effective

·         Process owner of quality systems such as, but not limited to; internal audits/self inspection, change control, management reviews, deviation management and CAPA

·         Compile and update training manuals, undertake induction training and refresher training related to QMS for local staff

·         Ensure quality agreements are established with 3rd parties

·         Ensure 3rd parties are qualified and maintained in an approved audit status

·         Ensure product samples are authorized with maintained traceability and product integrity

·         Decision of disposition for trade returns and damaged products

·         Authorization of any product from quarantine to approved product status

·         Maintenance, analysis and reporting of Quality KPIs

·         Ensure local repackaging of products is performed in accordance with specifications and required licenses

·         Review all packaging artworks from a local regulatory perspective as per internal and Corporate and local SOPs in place.

·         Develop and manage effective working relationships with competent authority and Galderma Global colleagues

·         Foster and maintain good cross-functional working relationships with other departments; attend cross-functional meetings and represent the Affiliate where necessary

·         Represent the company in the relevant committees of the professional/industry associations, if necessary

Technical skills - Education/Training

·         Bachelor of Science Degree in Pharmacy or Life Science

·         Technical skills - Work Experience:

·         Minimum five years’ experience in the pharma/medical device industry, preferably acquired in Regulatory Affairs or Quality Assurance departments

·         Knowledge of medical device GMP & GSP.

Technical skills - Required pre-requisites skills/experience for this position

·         Good knowledge of regulated products and the country/regional regulations and governmental authorities

·         Able to read, write and speak English fluently

·         Thorough knowledge of the local regulatory Guidelines and Corporate Standards and applicable laws.

·         Analytical skills

·         Good, positive and proactive communication and the ability to foster excellent working relations with external customers including the health authorities, industry associations and internal stakeholders

·         Skills such as project management, problem solving, ability to present information in easily understood format at internal and external meetings, good time management, negotiation and interpersonal skills

·         Ability to work both independently or as part of a team as required

·         Be proactive, motivated and a self-starter

·         Be able to balance company commercial needs with achieved compliance

·         Ability to think strategically and innovatively for resolution of quality issues

·         Commitment to continued improvement in department processes and performance

·         Strong team player, assisting others with workload peaks and the management of challenging situations

·         Proactively contributes to a positive team attitude and highly productive work environment

关于高德美, 一家皮肤科制药公司
皮肤是人体内独一无二的系统，所以皮肤病学要求专业的知识和专有的技术.高德美公司成立的初衷就是要创立一家专注于皮肤病学的制药公司.
在过去三十多年里，我们所有的资源和力量都朝向同一个方向：为粉刺、红斑粉刺、牛皮癣以及其他类固醇反应性皮肤病、甲真菌病（真菌指甲传染）、色素失调、皮肤癌的病人及医师提供创新性皮肤病学医疗解决方案，并针对皮肤衰老提供皮肤美化和纠正解决方案。我们治疗的各种皮肤状况其实是病人每天日常生活的强烈的心理和社会影响的投射所以在治疗这些疾病的时候，我们帮助病人维护，恢复和维持健康的肌肤状态，并改善他们的生活质量。
今天，高德美已经成为致力于为全世界提供创新性医疗解决方案、满足人们在人生不同阶段的需求并服务于全球医疗从业者的皮肤病学专业公司。公司拥有三十三家全资子公司，销售网络遍布全球，员工超过五千人，产品畅销七十多个国家。
我们每年投资的19%用于发现和研发全新的皮肤病学解决方案、产品和创新科技。高德美是世界上领先的皮肤病学研发企业之一。五家***研发中心，五座制造工厂，用于打造各种创意医疗解决方案，满足最高等级的安全性和有效性。