北京招聘

至少本科学历，3年以上软件质量工作经验，有咨询经验更佳。可以用英语熟练工作（口语和书写），有ERP，业务流程，软件测试，软件质量保证，以及医药行业，尤其是FDA标准知识。
您将在欧洲专家的指导下，共同进行医药制造ERP/LIMS/MES/WMS/DCS/SCADA/PLC的计算机系统验证，逐渐达到独立完成咨询业务，并成为业务带头人。
知识面广，能参与公司其他业务（BI，Java，Risk Management, etc.)。

Job description:
·Bachelor or higher degree, at least 3 years' experiences, consulting experiences are appreciated. Very good command of both spoken and written English.
You will work with our experts from Europe, participate in pharmaceutical ERP/LIMS/MES/WMS/DCS/SCADA/PLC validation, you should become independent in consulting, and lead this business' activities. With large computer software knowledges, you can participate in other activities of the company (BI,Java,Risk Management,etc.).

Detailed job description:
Qualified individuals will provide the following consulting services to our clients
·Validating “ERP” systems using established Computer System Validation (CSV) methodology such as GAMP 4 and GAMP GPG’s
·Execute quality assurance or authorship role on ERP SDLC processes such as: User Requirement Specifications, Functional Specifications, Business Process Procedures, Workflow Designs, Design Reviews, Design Specifications, Requirements gathering and Management, Risk Assessments, IQ/OQ/PQ Protocols, Traceability, Configuration Management, Change Control, Incident Management, Deviation Reporting, SOPs, Code Review, Test Strategy/Plans/Scripts, Validation Master Plans, Validation Summary Reports
·Provide guidance and facilitate regulatory Risk Assessments of GxP systems
·Maintain expertise in current and emerging cGMP requirements and quality trends
·Recommend and execute changes to quality standards to ensure conformance to regulatory requirements and industry "best practice"
·This position will entail travel to our client sites

Candidates must possess the following:
·Experience with pharmaceutical, medical device, and biologic manufacturing
·Experience in working with SDLC industry principles (e.g., GAMP, IEEE, etc.)
·Knowledge of FDA validation requirements as they relate to the pharmaceutical, medical device and biologics industries
·The ability to manage projects of a diversified scope and be able to influence cross-functional teams to achieve internal and external compliance requirements.
·Expertise in current and emerging cGMP requirements and quality trends
·Some knowledge of implementation tools used in the industry a plus; Mercury Interactive Test Director, Rational Requisite Pro
·2+ years of experience with compliance and validation
·3+ years of experience with ERP
·5+ years of experience in IT/IS
·Proven analytical and communication skills, both written and oral
·Proven organizational skills and project management skills

公司介绍
Micropole是一家欧洲知名的咨询和信息系统工程服务公司， 2000年在欧洲交易所主板Eurolist上市。拥有1300多名员工，9个法国办公点和5个欧洲办公点。Micropole于2011年进入中国，在上海成立了秘珀（上海）软件科技有限公司 （Micropole China Co.,Ltd），并在北京和香港设有分公司。2017年6月，Micropole在成都成立了研发交付中心。

公司业务
主要涉及商业智能（BI）、大数据、互联网和IT咨询（Web&IT）、客户定制化解决方案、生命科学领域计算机化系统验证等。

公司战略
1、推动欧洲公司在中国业务的发展，我们将根据中国市场的特点,实施高效的应用，在与全球信息系统相联系的同时，保证其相同的服务质量。
2、向准备进军欧洲的中国企业,提供满足欧洲客户需求的信息技术与应用。
3、通过咨询、设计、开发、实施服务，帮助中国企业取得快速发展。

我们期待着您的加入！(*****************)