苏州相关职位： 医药代表/学术推广专员（辉瑞欣母沛 - 苏州） Asia RA Manager Manufacture Engineer 注册专员 Senior Manager,Drug Production of GMP Pilot Plant 质量工程师 网络销售经理 临床监查员CRA 工艺技术员 档案管理员
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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5-7年经验 -
本科 -
招1人 -
11-09 发布
- 五险一金
- 补充医疗保险
- 员工旅游
- 餐饮补贴
- 通讯补贴
- 专业培训
- 年终奖金
- 股票期权
职位描述
职位描述： Summary 概述:Full time position for validation of the CMAB facilities and processes to global standards. The Senior Engineer, Validation has responsibility for:?Qualification and validation facilities, utilities, equipment, and processes including computerized systems, process equipment, and QC test equipment.?Writing and reviewing quality management documents related to validation lifecycle.?Supervising contractors performing commissioning and qualification activities.?Selection and operation of test equipment in execution of validation activities.?Presenting the validation status of systems and processes to Regulatory Inspectors and customers.?Audit and remediation of validation at contract manufacturing or test facilities used by CMAB.Principal Duties and Responsibilities 主要职责（包括但不限于）Site Safety?Comply with corporate and site safety procedures.?Take initiative to improve safety procedures where gaps are identified.Validation?Write and obtain approvals for validation Protocols and Plans including DQ, IQ, OQ, and PQ to meet international Good Manufacturing Practice (GMP) and quality standards for biologic products.?Write and periodically revise Validation Plans for facilities, equipment, utilities, production processes, cleaning, and Computerized Systems in collaboration with Subject Matter Experts?Hands on execution, witnessing and/or review of validation protocols.?Prepare and approve validation summary reports.?Review and approve Factory Acceptance and Site Acceptance Test (FAT and SAT) documents prepared by Vendors. Coordinating Protocol execution of testing with vendors and CMAB personnel.?Generate and review Qualification Deviations and managing their closure by the agreed dates.?Present validation status of systems and processes to Regulatory Agencies and at customer quality audits.?Specify, select, and coordinate purchase of testing equipment and associated consumables used in execution of qualification Protocols.Quality?Write SOPs and forms to cover the validation lifecycle of CMAB facilities, utilities, equipment, and processes (i.e. VMP, VP, URS, FS, DS, Protocols, Reports)?Identify validation requirements for proposed changes and corrective actions.?Comply with, and continuously improve, the Company QMS.Design?Generate and approving system- and component-criticality assessments.?Lead validation risk assessment workshops to document failure modes and mechanisms for control of critical-to-quality attributes.?Reviewi and approve specifications for compliance with company quality standards and performance criteria.Job Requirements 工作经验?B.Sc or B.E. plus minimum of 5 years professional experience within regulated bio/pharmaceutical organizatios or Masters Degree with at least 3 years of similar professional responsibility.?Minimum of 3 years responsibility for validation of PIC/S or US-FDA complaint pharmaceutical companies.?Experienced in operation of biopharmaceutical API facilities and/or aseptic product manufacturing.?Responsibility for validation during start-up of new facilities or major upgrade.OTHER KNOWLEDGE AND SKILLS REQUIRED:?Advance knowledge of validation and qualification practices as defined in current Good Manufacturing Practices.?Knowledge of the operation and first-hand experience with validation of bioprocess equipment (e.g. Bioreactors, chromatography systems, ultrafiltration systems) and/or aseptic filling systems (e.g. heat and steam sterilizers, isolators, packing lines) and pharmaceutical utility systems (e.g. PW, WFI, Pure Steam, Compressed Gasses, HVAC).?Previous hands-on experience mapping function and performance of controlled temperature environments such as refrigerators, freezers, and autoclaves using KAYE2000 system, standalone dataloggers, or similar.?Basic understanding of the validation of cleaning processes (CV), or manufacturing processes (PV), or Computerized System Validation (CSV).?At least basic understanding of QC test instrument qualification and analytical method validation.?Familiar with Good Automated Manufacturing Practice (GAMP)?Sound knowledge of Good Engineering Practices encompassing system design, factory testing, and commissioning.?Capability to analyze and summarize large amounts of information including sound statistical analysis knowledge to prepare summary reports.?Previous experience supervising contractors and small teams of up to 5 people composed of staff, consultants, and contractors.?Eye for detail and preference to work in highly structured manner.?Fluent oral and written Chinese skills and advanced communication skills in English to engage with personnel from multiple disciplines and experience bases to execute validation studies and represent validation status of CMAB facilities to customers and Inspectors..?Expert document writing skills using MS Office suite?Preferably Member of ISPE and/or PDA 职能类别： 生物工程/生物制药 医疗器械注册 关键字： Validation
联系方式
东平街188号
公司信息
苏桥医药（苏州）有限公司是一家致力于抗体及融合蛋白类生物药物的研发、工艺开发、及中试生产的高科技企业，服务范围全面覆盖临床前研究、临床研究、及商业化生产阶段。总投资额为4,640万美元。 苏桥医药是苏州生物纳米科技园（BioBay）重点扶持的企业之一。苏桥在园区内的建造面积共占地7,000平方米，目标产能1期实现69批次，2期实现92批次。 苏桥将严格遵守国际主流药品监管机构的质量标准，包括CFDA、USA (21-CFR) 、EMA (Eurdralex)、PIC/S以及 WHO。苏桥交付的生产样品能够满足客户在全球多个国家临床试验申请的CMC要求。
