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5-7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）?Assist in the establishment a corporate Quality Engineering, Qualification, and Validation programs.?Work with internal and external clients to provide suitable templates for qualification and validation templates for equipment, facilities, and processes.?Assist the Technical QA function with the implementation of Analytical Validation Templates as required.?Implement and manage the day to day operations for CMAB’s Change Management program.?Design and Implement the CMAB corporate Risk Management Program in partnership with the Engineering and Facilities Department.?Provide oversight to site metrology & calibration functions, technical service providers, and vendors to ensure compliance with all relevant policies and standards.?Ensure that the internal maintenance and calibration schedules are maintained.?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.?Train and develop staff to assist in and/or lead internal audits.?Participate in the execution of the internal auditing program to evaluate the compliance of cGMP operations for CMAB.?Assist QA management in hosting regulatory or due diligence inspections. Providing timely response and follow-up to any assigned observations.?Participate in the management of CMAB’s deviation, investigation and CAPA systems.Job Requirements/工作经验?BS degree, Engineering discipline preferred.?Minimum 5 years experience in QA for a regulated industry, pharmaceutical or medical device experience preferred.？Minimum 3 years experience in supporting site construction, qualification, and validation activities.？Preferred 1-2 years Supervising in a Quality Engineering function.?Expert 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.?Thorough understanding of mAb development, manufacturing, and analytical process.?Advanced level of English – reading, writing, speaking/comprehension & Native Mandarin.?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.?Advanced computer system and database skills – Excel, Word, Power Point, Outlook, etc.. 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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