Vicky Meng Email & Phone Number

Shanghai, China

Guangdong

Build quality team. 建立团队。 Establish and maintain quality system according to China GMP and EU requirements. 依据中国GMP以及欧盟要求建立和维护质量体系。 Develop Annual Quality Plan with remediation activities addressing compliance issues and risk signals. 建立年度质量计划及纠偏措施，着重体系的符合性和风险管理。 Monitor progress and effectiveness of remediation actions. 监督纠偏措施的进度和有效性。 On-site quality monitoring and file checks. 现场质量监督和文件审查。 Collaborate with related partners to facilitate inspections and audits as needed. 配合相关方进行现场检查和审计。 Lead regulatory strategy development for new project. 新项目的法规战略。 Provide regulatory expertise to product and cross-functional teams. 给予产品开发、团队提供法规知识。 Ensure timely regulatory filings or response to local CFDA or CE notified body. 与CFDA或CE公告机构及时沟通、资料准备。 Provide mentoring and coaching to junior staff members. 培养新人。 Establish strong relationship with regulatory authority and key related consultants or organization. 与政府当局、咨询机构或专家建立联系。 Participate in technical transferring from overseas companies. 参与国外技术引进。 Coordinate for new product development plan. 协调新产品开发计划相关工作。 Join the new raw material qualification and evaluation work. 参与原材料的挑选评审工作。 Provide innovative solution to support quality trouble shooting case. 对质量问题提供解决办法。 Review all the project related documentation and reflect good documentation practice during daily work. 审核项目相关文件，在日常工作中体现良好的文件实施、执行与管理。

Shanghai

Cooperating with US HQ and EU branch Company on several new factories or new products investigation, evaluation. 配合美国和欧洲公司工作，新供应商和新产品的调查、评估。 Collecting, preparing and searching proper domestic APIs, intermediates, finished formulas，and chemicals suppliers. 收集、寻找合适的国内原料、中间体、制剂以及化工品的供应商。 Confirming price and sample, checking quality according to customer’s requirements strictly. 确认价格、样品，严格按照客户要求复核质量。 Resolving complaints，rejection, returning payment or supplementary documents in time. Contact with sales dept. and QC directly accordingly. 与供应商、销售和质控部门进行三方沟通，及时处理投诉、退货、退款及补充文件。 Responsible for negotiation on Agency Agreements, Customer Protection Agreements and Confidential Agreements with China factories. 负责与中国供应商洽谈代理协议、客户保护协议以及保密协议。 Maintain the closely and friendly relationship with suppliers. 维护与供应商的良好关系。 Provide basic FDA or EDQM registration knowledge to suppliers. 为供应商提供FDA和EDQM注册的知识。

Shanghai

Contact with foreign pharmaceutical companies to set up Joint Venture (JV) companies at an initial stage, like Feasibility Study. 配合集团公司推进设立合资企业，与指定外企联系，准备可行性报告。 Establish business cooperation between international clients and company. 与国外客户和公司建立商务合作联系。 Coordinate legal, business and government requirements for projects. 协调项目相关的法务、商务和政府要求。 Attended various pharmaceutical exhibitions to develop new business and find the new clients. 参加各类药业展会，开发新客户，新商机。 Receive foreigners’ audit. 接待国外客人审计。

Training, International Project Management Professional Courses

Training, Interpreter Courses

进修, Mba

学士, Pharmacy