北京相关职位： 北京学术代表实习生 销售工程师/*** 高级销售代表（麻醉呼吸产品-医疗器械）-Sales-北京 医学部药物警戒实习生 医院资源维护经理 质量管理员 产品经理 河北省招商经理 物流配送员 (职位编号：4808) 生物实验员及质检质控
周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期： 2017-11-09
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无工作经验 -
招若干人 -
11-09 发布
职位描述
职位描述： Key responsibilities1.AuditingIndependently leads the planning, conduct and reporting of BioResearch QA routine and non-routine audits of activities, data, internal facilities and processes in GxP/non-regulated to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope. May support other auditors in planning, conduct and reporting of audits.Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.2.Inspection SupportParticipates in regulatory inspections in core and supporting roles3.Training & DevelopmentAssists in preparation and delivery of training materials. Advises and contributes to coaching.Completes training requirements in a timely manner to ensure inspection readiness at all times.4.Project ManagementTakes an active role in projects as assigned by supervisor and interacts with key stakeholders as appropriate.Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress.5.Subject Matter Expert / Point of ContactProvides expertise and knowledge to less experienced auditors, Business Partners and the core business sector on quality and compliance processes/procedures. Interprets and applies regulations/ policies to issues of moderate complexity, when required.Key skills1.Teaming & CollaborationCollaborates with peers, managers, and Business Partners to create an effective team environment.Provides a high level of technical and relational contributions.Develops relationships to build trust with team members and business partners to achieve goals.Identifies issues and recommends actions towards effective solutions.Manages team dynamics.2.Degree of Supervision, AutonomyWorks independently for routine and non-routine activities; may need minimal supervision for more complex issues.3.Problem SolvingUnderstands and takes action to resolve problems of moderate complexity and is able to identify key stakeholders.Seeks advice on complex issues.4.InnovationIdentifies and communicates meaningful risks and takes appropriate action.Challenges the status quo and adapts to change; contributes to meaningful innovation through translation of insights into innovative and viable solutions.Uses insight to uncover important unmet needs.5.Communication & InfluencingUses fact-based evidence to defend position when challenged. Focuses on achieving the best outcome for the situation.Communicates and interacts effectively at all levels. Clearly expresses opinions and new ideas.Engages in transparent and constructive conversations, contributing to high-performing teams. Influences the creation of a trusting, collaborative and ethical work environment that positively contributes to employee engagement.Expected to maintain awareness of the regulatory and clinical research/pharmaceutical industry environment and, as a result, has the ability to influence internal Business Partners on best quality & compliance practices and to form quality mindset. Demonstrates good negotiation skills. Establishes contacts with Quality professionals in the clinical research and pharmaceutical industry.Education:A Bachelor of Science (BSc) or Arts (BA) degree or the equivalent in training and experience is required. Preferably 5 years in an R&D environment.Related Experience:?Comprehensive knowledge of the drug development process, applicable regulations (GxP), R&D practices, and scientific and quality terminology.?Expertise in one or more specific compliance disciplines (non-regulated, GLP, GCP, PV or computerized systems) preferred.?Knowledge of procedural and records management requirements in a regulated industry preferred.?Prior pharmaceutical and quality/compliance related experience preferred.General Skills:?Excellent communication skills?Fluent written and spoken English is required?Team Player?Organized and detail oriented?Sound problem solving and good negotiating skills?Proficient in Microsoft Office applications?Quality mindsetWorking conditions/Travel requirements:?Overnight travel, nationally and internationally, up to 40% . 职能类别： 药品生产/质量管理
联系方式
北京市朝阳区建国路77号华贸中心写字楼
公司信息
公司简介(中文) 恢复为 “成立于1985年的西安杨森制药有限公司（“西安杨森”）是中国最大的合资制药企业之一，也是中国改革开放以来进入中国的最早一批制药公司之一，其总部位于北京的中央商业区。西安杨森是强生公司的一员。从创立之初，西安杨森就致力于引进和生产许多创新产品和高质量产品。西安杨森一直致力于投资未来，计划增加在生物制品、心脏病学、风湿病学和泌尿科学领域的新系列产品。西安杨森致力于利用这些新药改善中国患者的医疗保健状况。 本着公司信条和关爱精神，西安杨森一直是活跃的企业公民，在医药、公共卫生、药物研发领域和企业社会责任方面从事了五十多项合作项目。例如，西安杨森与中国卫生部国际卫生交流与合作中心合作创立了“吴阶平医学研究奖和保罗•杨森药学研究奖”，旨在鼓励医药学领域的工作者不断创新。在过去的17年中，共计305名杰出医药学工作者在45个专业领域获得了该奖项，他们在科研领域做出了大量有价值的创新。 此外，西安杨森也被誉为培养制药行业人才的摇篮。1999年，西安杨森被财富杂志（中文版）评选为“中国最受敬仰的十大外资企业之一”。2005年，西安杨森被中国中央电视台评选为“***雇主”，并且分别在2008年、2009年和2010年获得了“中国大学生***雇主奖”。 目前西安杨森所有的招聘信息仅通过前程无忧，智联招聘和猎聘网进行发布，任何在非上述三家招聘网站看到的信息均非西安杨森正式发布。为避免对您的合法权益造成伤害，请务必通过正规渠道投递简历。 2013年，强生在西安高新区投资兴建强生全球供应链先进的生产基地，该项目建设目前已正式启动。新生产基地占地267,000平方米，将取代西安杨森在西安新城区现有的生产基地，成为强生供应链在亚洲的创新枢纽，从而更好地满足中国和其他新兴市场不断增长的需求。新的生产基地将采用世界***的制造技术和先进的质量体系，并引进集电子批号记录和数据存储于一身的全自动化配方生产操作系统以及先进的德国进口生产工艺设备。
