CSV & ERES Compliance Director 无锡

月薪： 50-80万/年

该公司所有职位
  • 10年以上经验
  • 本科
  • 招1人
  • 12-21 发布

职位描述

Job Responsibilities:Position Summary:This position ensures compliance of computerized systems and associated processes with Wuxi Bio, and expectations of Regulatory authorities, including but not limited to a complete system life cycle approach to computerized systems with a focus on 21 CFR Part 11 compliance and validation using current industry norms (e.g. GMAP 5, PQLI (ISPE), ICH, PI C/S and ASTM E55). The primary responsibility is to provide the quality oversight to ensuring life cycle validation and compliance of computerized systems and their associated platforms working with the system owners and end users as key stakeholders.1.Automation and CSV for WuXi Biologics in general and the Wuxi Bio MFG2 facility in particular.2.Establishing ERES and CSV/computerized system ERES compliance part of QMS (QM part, QSGs, SOPs and CSV validation/compliance documents).3.Working closely with QC, MFG/FFF, ENG, Operation, QA, and IT to achieve and maintain Computerized Systems and ERES compliance.4.Lead and act as the key contact person / SME for all issues related to Computerized Systems and ERES compliance during routine quality operation, internal/external audits, health authority (HA) inspections and client communication.5.Serve as a Computerized System Validation Subject Matter Expert and provide strategic guidance. Determine and establish validation requirements for computerized systems based on SOPs and regulatory standards (FDA, EMA) to ensure compliance and maintain an inspection ready state.6.Lead the development of system specific validation plans and strategy using a risk-based approach.7.Provide (modular) training of validation engineers and / or consultants to effectively produce validation deliverables following CSV SOPs and FDA 21CFR Part 11 requirements.8.Provide regular updates related to key accountabilities and scope of the job to senior management.9.Ensure quality of CSV deliverables for regulated systems and quality of non-regulated systems.Personal Qualification:1.BS in Engineering, Computer Sciences, or related field.2.At least 10 years of working experiences in the field of computerized system validation in the pharmaceutical industry. Additionally, have more than 5 years of working experiences in engineering fields.3.An expert in related regulatory requirements and industry standards, such as 21 CFR Part 11/210/211, Annex 11 of EU GMP, GAMP 5, ICH Q9/Q10.4.Proficiency in: SAP, LIMS, MES, DCS, Empower, automation, and other pharmaceutical IT systems; Data Management Systems.5.Proficient speaking and writing in English. Having similar skills in Chinese is a plus. Excellent technical writing skills in English is required.6.Excellent training skills for providing both classroom training and on the job training of CSV and ERES compliance. 职能类别： 生物工程/生物制药

联系方式

无锡滨湖区马山梅梁路108号

公司信息

使命 我们的使命是转变和加快制药发现、开发及在快速成长的生物制剂领域造福全球患者。 公司简介 药明生物技术（药明康德关联公司）提供全面、综合及可高度订制的生物制剂发现，开发及生产服务。我们是世界上唯一的开放式生物制剂技术平台，提供端到端解决方案，让任何人能从概念到商业化生产过程中发现、开发及生产生物制剂。我们提供的单源式服务为客户节省了宝贵的项目时间和费用。我们公司的历史和成就证明了我们为全球客户提供真正的一站式，开放式服务的价值主张和承诺。 更多信息，请登录公司官网：http://www.wuxibiologics.com.cn/

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企业入驻日期： 2017-11-09

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