Specialist, Technical Quality/工艺质量专员 苏州

月薪： 0.5-1万/月

该公司所有职位
  • 3-4年经验
  • 本科
  • 招1人
  • 11-22 发布

职位描述

职位描述： Principal Duties and Responsibilities/主要职责（包括但不限于）?Provide technical quality oversight for the analytical and laboratory functions at CMAB.?Assist in the selection, implementation, qualification, and validation of the CMAB Corporate Laboratory Information Management System(s) [LIMS].?Qualify as a ‘Super User’ for the LIMS system(s).?Assist in the development and training for CMAB staff on the efficient and proper operation of the LIMS system(s).?Support LIMS Systems Owner with operational oversight for the day to day management of the LIMS system(s):?Ensure timely reviews and approvals for analytical data.?Ensure document change processes coordinated and compliant with CMAB’s analytical method qualification and validation.?Align with the Change Management function to ensure coordination of document changes with equipment, material, and process, changes.?Provide suitable metrics to Site and Quality management allowing visualization of document status, periodic review, and integration into the CMAB Deviation and CAPA management system(s).?Support lead auditor, in routine and supplier audits as required, perform audits of internal operational departments and associated systems to ensure compliance and adherence to approved CMAB policies and procedures.?Assist QA management in hosting regulatory or due diligence inspections. Providing timely response and follow-up to any assigned observations.?Participate in the execution of the internal auditing program to evaluate the compliance of cGMP operations for CMAB.?Support CMAB’s deviation, investigation and CAPA systems.Job Requirements/工作经验?BS degree, engineering or scientific discipline preferred.?Minimum 3 years experience in QA for a regulated industry, pharmaceutical or medical device experience preferred.?Minimum 1-2 years experience in laboratory (Quality Control) with understanding of software qualification and validation.?Thorough knowledge of Biopharmaceutical Manufacturing Operations operating under the control of Good Manufacturing Practices including PIC/S and US-FDA with focus on biological API and sterile product manufacture.？Thorough, in-depth knowledge of Global GMPs and Heath Authority guidelines, with an emphasis of Annex 11/Part 11 compliance.?Expert understanding of mAb development, manufacturing, and analytical process.?Advanced level of English – reading, writing, speaking/comprehension & Native Mandarin.?Advanced computer system and database skills – Excel, Word, Power Point, Outlook, etc.?Excellent communication skills in Chinese and English to engage with personnel from multiple disciplines and experience bases across the organization and client base.?Exposure to company and facility start-up.?Strong prioritization and organization skills.?Detail oriented, flexible, self-initiative. 职能类别： 生物工程/生物制药

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。

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