医药之梯,一个专业的医药人才招聘网站!
, 欢迎您!

GMP合规副主任

面议

无锡市本科及以上

刷新时间:3天前

职位描述

• Organize regular inspection and GMP training to Support Production and WH team to improve GMP requirements awareness.
• Lead Training and document control coordination to meeting internal requirement.
• Take part in set-up of Assembly Center pertaining to SOPs and OJT creation.
• Initiate, Review and advise on gamma irradiation and equipment qualification protocol design and reports.
• Initiate, Review and advise on AC study protocol design and reports.
• Upon detecting any major incompliance alert, escalate to senior management to take corrective action and /or preventive measures.
• Initiate, Review change controls reports and deviation reports.
• Participate in internal audits.
• Seek opportunities to work collaboratively with peers and other stakeholders to identify areas for enhancement, development and to implement cohesive solutions that benefit the broader organization.
• Inspire logical thinking and good English writing.

工作要求

教育程度/经验Education background/ Experience
• Bachelor and advanced degree in natural science (chemistry, pharmacy, biology, chemical engineering or related pharmaceutical science).
• More than 15 years in the biopharmaceutical industry in Manufacturing, Quality, Technical or Regulatory position or a combination of thereof, and/or worked with regulatory health authorities or pharmaceutical clients.
• Experience leading or supporting sites or functions in health authority/client inspections is desirable.
特别知识Special knowledge
• Knowledge on sourcing updated regulatory requirements on GMP and GDP from Asia, US FDA, EMA, WHO, ICH, PDA and ISO and implementation.
• Demonstrated ability to apply effective risk management approaches that entails identification of risk up to implementation of effective mitigation plan.
技能Skills
• Demonstrated ability to make and act on a decisions while balancing speed, quality and risk.
• Good knowledge and hands-on management experiences in GMP manufacturing environment with Pharmaceutical Quality System.
• Demonstrated ability to work independently and with groups of people/teams in a complex changing environment.
• Ability to think critically, clearly and in a decisive manner; remain calm under adverse conditions.
• Pragmatic in approach with demonstrated ability to make sound, risk-based decisions
• Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering commitments.
• Savvy in information technology

其他要求

  • 1人
  • 质量部经理/主管

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业,总部位于杭州,下属有上海、南京、广州、武汉等多家分公司,同时自主开发国内领先的猎头办公系统及医药人才网站,全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台,在欧、美、日等国家建立了海归引进平台,同时积极开展医药高等院校公益系列讲座,搭建了以人力、企业为主体的立体化咨询服务网,为医药企业人才队伍建设发挥了积极重要作用,为很多医药企业解决了高端人力之困。

网站备案号:浙ICP备12009347号-3 浙公网安备 33010602000646号 人才服务许可证:330101000577号

版权所有 Copyright ©2010- Olinking.com All Rights Reserved.

反馈
建议