Quality Assurance Manager 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： The Quality Assurance Manager supervises and coordinates auditing activities to ensure compliance with SOPs and cGMP requirements. Supervises and manages QA team members. Performs a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements by conducting audits and inspections, supporting training programs, data and documentation reviews.Responsibilities:1.Establish, oversee and expand an on-going Corporate Quality Assurance program to ensure overall quality compliance with Current Good Manufacturing Practices (cGMPs) and all other governmental regulations and company standards.2.Ensure the compliance of manufacturing and testing activities with respect to procedures, as well as FDA, EU, ICH.3.Assist in the development, implementation and maintenance of quality assurance programs. Ensure documents and records are kept in compliance with regulations and SOPs.4.Conduct internal and documentation audits, as assigned. Reviews audit plans/reports5.Supervises and coordinates vendor audits of subcontractors.6.Supervises facility audits compliance issues and procedures of departments and recommends solutions to problems or changes in procedures.7.Reviews Standard Operating Procedures (SOP) for GMP compliance.8.Supervises and directs Quality Assurance staff, includes: scheduling, development, performance evaluations, disciplinary actions, etc.9.Reviews validation projects; and oversees audits of validation data and reports.10.Lead and/or support project teams developing new or improving existing Quality Management Systems. Participate on cross-functional teams to support relevant quality requirements.11.Support in the identification and assessment of quality systems compliance risks and needed risk mitigation strategies.12.Support Regulatory and Health Authority Inspections on Quality Systems and GxP Document Management.13.Reviews and manages CAPAs for a timely resolution.14.Develops and delivers staff training regarding quality and regulatory matters.Job Specific Skills:1.Familiar with pharmaceutical GMPs and contemporary Validation requirements.2.Hands on experience with SOPs, batch review, deviations, CAPA development and batch release.3.Ability to work independently, flexibly and adjust to changing priorities in a fast-paced environment.4.Excellent attention to detail, time management and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines.5.Excellent interpersonal, verbal, and written communication skills.Requirements:1.Bachelors in a technical or medical science; advanced degrees highly desired.2.At least 5 years of experience with implementing and maintaining pharmaceutical quality systems in a current Good Manufacturing Practices (cGMP) environment.3.Experience writing and presenting clearly on quality topics.4.Must be able to communicate effectively with staff, customers, regulatory Authorities, and peers.5.Possess thorough knowledge of GCP, and regulations including FDA, EU Directives, ICH and 21 CFR Part 11 / EU Annex 11. 职能类别： 药品生产/质量管理 关键字： QA cGMP FDA

联系方式

苏州相城区苏相合作开发区湖村荡路16号

公司信息

长风药业股份有限公司是一家以专业开发肺部给药和其它药物输送技术为主，以国内外市场为导向的高科技制药企业。目前研发产品涉及治疗哮喘、慢性阻塞性肺病（COPD）、心血管疾病和抑郁症等领域。 公司的创业团队先后荣获“江苏省创新创业高层次人才”、“科技领军型团队”及“国家千人计划”等奖项。 长风于2010年12月与中国著名上市医药企业北京双鹭药业达成战略投资合作协议，协助长风医药产品上市和销售。 公司发展战略是为全球医药市场提供技术含量高、质量好、临床效果佳的药物。公司集合了创始人在国际医药领域的丰富研发经验和中国高素质人才的研发优势，从而保证公司为全球医药市场提供高质量的产品和优质的服务。 长风注重人才和现代化企业文化建设，在高速发展业务的同时，也极大限度地支持员工个人的职业发展。 公司生产中心位于苏州市相城区，是当地政府重点关注的药企；研发中心位于被冠以“太湖慧谷”的K-PARK无锡太湖新城科教产业园，拥有良好的工作环境。东临规划中的无锡行政中心，西与中央影视基地、鼋头渚接壤，南为雪浪山生态风景区，北枕五里湖畔。无锡地铁一号线从园区穿越而过，与各交通基点四通八达。

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