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Quality Compliance Audit Director

面议
江苏-无锡 -滨湖区 | 10年以上经验 | 本科学历
2020-03-08 更新 被浏览:
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职位描述
招聘人数:1 人 性别要求:不限性别 Job Description:Build the internal quality compliance audit program & Qualified auditor group. Ensure the alignment and adherence to the global quality system across sites via internal audit.Independently lead/participate on GMP compliance audits and identify GMP compliance gaps or risks. Provide GMP compliance expertise to internal customers. Perform tasks and work to achieve company goals and organizational objectives. Lead and Participate in audits which include preparing the audit plan/agenda, conducting the site audit, developing audit report to address the individual gaps and system gaps. Follow up the remediate action for the findings, including evaluation of the response from the internal customers for identified audit findings. Identifies gaps/risks in corporate practices, policies and procedures and prioritizes based on current regulatory environment, guides and regulations. Tracking the regulatory inspection trend, e.g. reviewing FDA-483 observations, EIRs and audit findings &Working with the data analysis team to analysis the internal compliance data analysisSupport the team leader to set 4. up the internal quality compliance audit program including procedure/plan/audit aide memories/report template, etc. 5. Participates in response development to regulatory inspection observations if necessary. Author responses if assigned. Acts as a SME for corporate internal audit team. 6. Participate as an internal compliance team representative in relative meetings to communicate with the stakeholders the compliance status, e.g. communicate the compliance issues/risk with the team, provides input on issues discussed of resolution, etc. 7. Act as the trainer to site internal auditors. 8. Set personal performance goals and provide input to departmental objectives. 9. Perform any other tasks as requested by management to support quality oversight activities.
Qualification:Bachelor/Master degree and above.Major in life science, biology or biochemistry is preferred.With 5 years of experience in QC or product development or process in biotech product.With more than 15 years quality management, compliance or other relevant experience in sterile drug manufacturing.With the experience of corporate quality audit of sterile/bio- product is preferred.With consolidate knowledge of the GMP regulations (CFDA/ EMA /FDA/ICH, etc.) and guidelines.Good communication and coordination skills both in oral and written.With fluent oral English and good English listening, reading and writing ability. Familiar with the operation of quality management software (e.g. trackwise, e-doc) and office software.
求职提醒:求职过程请勿缴纳费用,谨防诈骗!若信息不实请举报。
该公司的其他职位
  • 合资企业
  • 200-500人
药明生物(股票代码:2269.HK)作为一家香港上市公司,是全球领先的开放式、一体化生物制药能力和技术赋能平台。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务,帮助任何人、任何公司发现、开发及生产生物药,实现从概念到商业化生产的全过程,加速全球生物药研发进程,降低研发成本,造福病患。截至2018年6月30日,在药明生物平台上研发的综合项目达187个,包括98个处于临床前研究阶段,78个在临床早期(I期,II期)阶段,10个在后期临床(III期)以及1个在商业化生产阶段。预计到2021年,公司在中国、爱尔兰、新加坡、美国规划的生物制药生产基地合计产能约22万升,这将有力确保公司通过健全强大的全球供应链网络为客户提供符合全球质量标准的生物药。如需更多信息,请访问:www.wuxibiologics.com.cn。
药明生物员工总数超过4000人,其中300多位是具有海外高等学位和工作经验的海归科学家,拥有欧美市场抗体开发、生产、质量控制、临床前研究和国际注册经验,高级管理层团队成员均工作在生物制药行业一线,并在各自专业领域平均拥有超过20年行业经验,打造了世界一流的生物药发现、开发及生产团队。
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