Associate Director II - Validation招聘_上海药明生物技术有限公司最新招聘信息-猎才医药网

职位描述

职位描述： 1 目的PURPOSE1.1 明确GMP培训岗位的职责及资质要求To clearly define the job description and qualification of Validation Director in PEV Department.2 职责DUTY2.1 汇报范围Scope of the Reporting Structure2.1.1 Direct supervisor: Director, Validation, PEV2.1.2 Direct subordinate: Team Leaders, including Senior Manager, Manager, and Assistant Director.2.2工作职责Job ResponsibilityPosition Summary: Manage validation & qualification activities and system lifecycle from requirements analysis or product development to commercialization manufacturing, covering various equipment/facilities/utilities/computer systems or cleaning/analytical methods/processes.Essential Job Responsibilities:1. C&Q？Lead the functions, including but not limit to the activities of C&Q, validation, in R&D and Commercial Facility;？Support the validation function of all existing and future sites in WuXi Biologics;？Support PEV Senior Director with the development of the new biotech manufacturing facilities.？Support engineering related audit/visit by clients and regulatory authorities;？Ensures that the commissioning and qualification of the Commercial Manufacturing Facility comply with appropriate regulatory requirement and construction code;2. Cleaning, Process Characterization and Process Validation？Serve as an SME of Cleaning Validation, Process Characterization and Process Validation and provide strategic guidance.3. CSVEnsures compliance of computerized systems and associated processes with Wuxi Biologics, 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 , and PI C/S ). 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.？Automation and CSV for WuXi Biologics in general and the Wuxi Bio MFG2 facility in particular.？Establishing ERES and CSV/computerized system ERES compliance part of QMS (QM part, QSGs, SOPs and CSV validation/compliance documents).？Working closely with QC, MFG/FFF, ENG, Operation and IT to achieve and maintain Computerized Systems and ERES compliance.？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.？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.？Lead the development of system specific validation plans and strategy using a risk-based approach.？Provide (modular) training of validation engineers and / or consultants to effectively produce validation deliverables following CSV SOPs and FDA 21CFR Part11 requirements.？Provide regular updates related to key accountabilities and scope of the job to senior management.？Ensure quality of CSV deliverables for regulated systems and quality of non-regulated systems.4. PAILead Site PAI (pre-approval inspection) and compliance program.？Validation (CSV and C&Q)？ENG SOP upgrade？ENG (BMS/FMS)3.0 人员资质 PERSONNEL QUALIFICATION3.1M.S. in chemical engineering and biological engineering discipline with minimum 15 years of hands-on and management in validation and engineering in pharmaceutical and biopharmaceutical industry. At least 10 years in validation management.; PhD degree in the same discipline with minimum of 10 years of related experience;3.2An 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; ISPE Baseline Guides, and PDA TRs in Cleaning and Process.3.3Proficient in: SAP, LIMS, MES, Empower, automation, and other pharmaceutical IT systems; Data Management Systems.3.4Strong collaboration, communication and influence skills;3.5Good knowledge and experience in GMP, Quality System, EHS;3.6Fluent in written and verbal English communication. 职能类别：生物工程/生物制药

公司信息

药明生物（WuXi Biologics）是香港上市公司（代码：2269），我们是全球领先的开放式、一体化生物制药能力和技术平台，旗下包括无锡药明康德生物技术股份有限公司、上海药明生物技术有限公司、苏州药明康德检测检验有限责任公司，并在美国和英国设有子公司。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务，帮助任何人、任何公司发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。目前，公司规模达到2300多人，有200多位拥有海外高等学位和工作经验的海归科学家，拥有丰富的欧美市场抗体开发、生产、质量控制、临床前研究和注册的经验，打造了世界一流的生物药研究、开发及生产团队。更多信息，请登录公司官网：http://www.wuxibiologics.com.cn/

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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