Specialist, Manufacturing QA 苏州

月薪： 6-8千/月

该公司所有职位
  • 3-4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）?Provide Quality Assurance (QA) oversight in Manufacturing operations to ensure that the manufacture of product and maintenance of the facilities are in compliance with SOPs, policies and cGMP / GDP guidelines?Review batch production records and associated documents to ensure compliance with SOPs and policies?Manage discrepancy management system to ensure that deviations are appropriately assessed and reviewed to ensure compliance with SOPs and policies?Participate in the assessment, review and approval of change controls and corrective / preventative actions?Participate in the development and / or review of related SOPs and policies to support batch production and product release.?Perform assigned tasks while meeting timelines to achieve company goals and department objectives.?Assist MQA Sr. manager in handling regulatory or due diligence inspections. Oversee the timely response and follow-up to any observations.?Assist all CMAB functional areas in managing CMAB’s deviation, investigation and CAPA systems.Job Requirements/工作经验?BS degree, scientific discipline preferred.?Minimum 3 years experiences in MQA for a regulated industry, pharmaceutical or medical device experience preferred.?Advance 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. Must have a proven ability to communicate effectively in both a written and verbal format.?Exposure to company and facility start-up.?Detail oriented with strong leadership skills and excellent interpersonal and communication skills.?Demonstrate effective problem solving, strong understanding of regulatory affairs, excellent interpersonal skills and the ability to prioritize multiple tasks.?Ability to work both independently or collaboratively in a team structure. Have a proven ability to work well under pressure.?Strong prioritization and organization skills, 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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企业入驻日期： 2017-11-09

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