Supervisor, Quality Control Characterization 苏州

月薪： 15-20万/年

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： Principal Duties and Responsibilities/主要职责（包括但不限于）?Supervise a team of Analysts to ensure compliance to CMAB and regulatory standards/policies.?Provide continued coaching and developing of subordinates to help them meet both their career and personal development goals and to ensure a cohesive, productive and highly motivated team?Manage and support analysis of characterization data as directed with the ability to establish and determine suitable comparability requirements in support of process transfer and process and method development?Ensure raw materials, in-process and finished formulations products are analyzed, documented in accordance to quality requirements and provide accurate test results for product release decisions in adherence to testing lead time.?Ensure that documentation and laboratory processes are in a constant state of regulatory compliance and inspection readiness.?Responsible for ensuring that all personnel involved in testing are trained in basic cGMP training and are getting routine updates in cGMP information and training?Author and review Change Controls, Deviations/lnvestigation as well as Test Methods, Specifications and SOPs?Responsible for data and logbook review?Customer and regulatory agency interaction as required?Work interdepartmentally to enhance communications at all levels and ensure that work orders, preventative maintenance, compliance and documentation issues are resolved?Assist in reporting writing (Example: Deviations/ Investigations)?Involved in QC equipment qualification?Ensure regulatory inspections readiness, represent area and participate in audits.?Continually review and improve the Quality Control's operational support and efficiency?Participate and support in analytical method transfer and qualification following approved protocolsJob Requirements/工作经验?B.S. (preferably Biology or Chemistry) plus a minimum of 4 years in a quality control and compliance function for the manufacture of therapeutic biologics.?Experience in a regulated biopharmaceutical manufacturer with exposure to facility start-up.?Solid knowledge of Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP) encompassing documentation and operation of pharmaceutical facilities manufacturing therapeutics for clinical or commercial purposes in accord with international cGMP standards.?Understanding of mAb development, manufacturing, and analytical process.?Experienced and active participation in a robust change management system:?Document Management?Change Control?CAPA and Deviation?Training?Highly skilled in computer system and database operation.?Ability or willingness to investigate and solve complex technical problems?Good communication skills in Chinese and English to engage with personnel from multiple disciplines and experience bases across the operations organization.?Good problem solving and analytical skills?Decision Making — Able to recognize important information necessary for solving problems. Able to identify when to escalate an issue. Objective in decision making/wiil consider alternative solutions.?Planning/Organizing - Identifies critical activities and assignments and adjusts priorities appropriately. Uses resources to complete tasks efficiently. Keeps effective control over tasks. Develop plans. 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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