北京招聘

Description

The QA Manager will provide support to management in the promotion and assessment of compliance with regulations, guidelines, and operating procedures; manage QA oversight of projects, assignments, and training; conduct independent audits to assess compliance with regulations, guidelines, and operating procedures; prepare and distribute reports of findings to operations staff, management, and customers and provide consultation in interpretation of regulations, guidelines, policies, and procedures.

Responsibilities:
? Planning, scheduling, conducting, reporting and assuring preparation and implementation of corrective action plans for various audit activities associated with the conduct of Phase II-IV clinical trials.
? Evaluating audit findings and preparing and distributing reports to operations staff, management, and customers.
? Providing interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
? Presenting educational programs and providing guidance to operational staff on compliance procedures.
? Evaluating policies and procedures for compliance with applicable regulations/guidelines and providing recommendations to management for continuous process improvements.
? Hosting audits conducted by VPS customers.
? Hosting regulatory inspections.
? Providing training for new Quality Assurance staff.
? Serving as author of Quality Assurance SOPs as assigned.
? Acting as a Regional or Global QA Lead for assigned customers projects
? Overseeing documentation, reporting, and closure of compliance issues
Qualifications

Bachelor's degree with 7 years Quality Assurance experience in pharmaceutical, technical, or related area; or equivalent combination of education, training and experience including experience in working with GCP requirements.
? Knowledge of word-processing, spreadsheet, and database applications.
? Extensive knowledge of pharmaceutical research and development processes, GCP and the regulatory environments.
? Considerable knowledge of quality assurance processes and procedures.
? Strong interpersonal skills.
? Excellent problem solving, risk analysis and negotiation skills.
? Exceptional training capabilities.
? Effective organization, communication, team orientation, and leadership skills.
? Ability to work independently with initiative.
? Ability to manage multiple projects.
? Ability to establish and maintain effective working relationships with coworkers, managers and clients.

万全是一家中国领先研发驱动数字生态的跨国医药服务组织。一家互联网垂直整合下4O平台（PDO-CRO-CDMO-ADPO ），旗下两家关联上市公司。
·德众万全PDS ：载誉15年，中国新药研发批准排名最前列，获***新药四百多件，申请专利千项；
·阳光万全CRSO：让世界为中国临床研究喝彩，参与30多项国家973，十二十三五国家重大创新和参与获得国家创新一等奖；
·万特制造云CDMO：六家制造基地通过WHO等国际认证；
·万德玛ADPO： 中国新药沃尔玛，科研临床推广和互联营销的推广的先行者！

创新的万全之技 健康的万全之策
——我们曾经骄傲的宣称我们是中国制药的发动机，上千专利，15年研发领先，未来产品最多拥有者。填补国内多项空白技术：靶向给药，脂质体给药，口腔崩解剂都是国内***;我们也曾经如此刚到光荣，全国高端临床研究，国家十二五十三五重大专项有我们的组织，国家科技进步奖阳光万全是最多的获奖和引领者。

健康的万全之策
——不忘初心万全在许多重大疾病治疗影响非凡
1. 喜恩万全:心脑双喜，这个脑科学领域最响亮的名字在国家脑科学战略中提出六大组方。《喜恩formula1:StartD解忧组方》；《喜恩幸福组方曲优+乐孚亭》《喜恩卒中防治7组方》《喜恩解忧防治卒中》提出治疗卒中的第四干预治疗方案，《喜恩癫痫防治领域》，《喜恩抗痴联合组方》
2.万全在中国***致死率的疾病卒中方面。
3. 万全在全球***流行疾病吸烟成瘾疾病方面，健康中国戒烟国策，吸烟是致命的***流行疾病。悦亭不仅是全球戒烟处方领导者。
4 .本世纪最难攻克和最昂贵的疾病要属老年痴呆 。
5 .过敏顽症之世纪流行，中国儿童几乎超过每三个就有一个过敏。拜敏Bye，拜拜过敏全球抗敏领导者。
6.卡地万全健康心脏五大处方，卡地健康心脏（亚洲）研究院。
7.健寿万全抗痴衰研究中心。这个中心有个宏伟的计划，就是重新筛选改变对现在药品和医疗的认知，让人类可以健康不受疾病困扰（健寿）地多活数十年
8..渐冻人ASL这个世界五大绝症，万全不仅四千人为爱捐款，同时万全罕见病渐冻人中心的万全力太成为救命的***药。