QA Manager, Documentation Control

职位描述：
  • Develop the document control management system to meet FDA and global compliances.
  • Generate and maintain controlled documents, manage the document change control system and processes including the receipt, maintenance, approval, distribution and storage of controlled documents such as standard operating procedures, forms, master batch records, protocols, reports, methods and specifications and other quality documents.
  • Responsible for maintaining hard copy and electronic master documentation including but not limited to electronic logs and index’s of controlled documents, templates, and related records.
  • Ensure processed documents are complete, concise, accurate and conform to established formats.
  • Perform word processing and publishing tasks on a variety of quality documents.
  • Maintain and distribute required approved CMC documents to/from all related departments and outside contractors. 
  • Maintain training records and personnel qualification files and ensure ongoing training compliance for GXP colleagues.
  • Organize and maintain Master Index of documents archived off-site.
  • Distributes and retrieves, when applicable, documents to/from all concerned departments.
  • Maintain and coordinate activities related to the document system including generating, revising, obsoleting the requirements and operational procedures for internal and external documents.
  • Ensure controlled documents are periodically reviewed for compliance.
  • Provide expertise and input to other functional areas affecting controlled documents.
  • Assist in the coordination and compliance with requests of regulatory authorities during inspections and audits.
  • Create templates for controlled forms.
  • Administer the periodic review system.
  • Write Standard Operating Procedure (SOP) for the creation and development of the Document Control processes 
  • Develops and implements continuous improvement programs. 
职位要求：
  • Bachelor’s degree with at least 8 years in pharmaceutical industry.
  • Minimum of 6 years in document management, including developing, implementing and managing controlled documentation systems.
  • Excellent record keeping skills.
  • Detailed oriented and outstanding organization skills.
  • Knowledge of QA documentation process and Good Documentation Practices is preferred. 
  • Ability to work under aggressive timelines and multiple task assignments.
  • Extensive knowledge of cGMP regulations, ICH guidelines and international compliance requirements for CMC.
  • Excellent communication, organizational, interpersonal and computer skills.
  • Thorough understanding of FDA expectations on GXP compliances.
  • Supervisory and management experience.
  • Prior experience in a biotech or GXP-regulated industry is strongly preferred. 
  • Strong computer skills in Microsoft Word and Excel are required. 
  • Strong self-motivation and ability to work independently and in a team environment. 
  • Strong follow up, organization and prioritization skills. 
  • Capable of communicating in English is a plus.
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绿叶制药集团
公司介绍
Welcome to join Luye to achieve your dream！

Luye Pharma Group Co., Ltd.is a professional pharmaceutical enterprise listed on the main board of the Hong Kong Stock Exchange (02186.HK). We’re committed to providing high quality medical products and professional services to human health . And we’re committed to be the most respectful leading global pharmaceutical enterprise.If you are passionate about continuous innovation and overseas careers, here we can offer you a new brighter future.

    绿叶制药集团是一家以研发为基础的专业制药企业，公司成立于1994年，2014年在香港主板上市(02186.HK)。公司在烟台、北京、南京、泸州和德国米斯巴赫设有生产基地，在中国、美国和欧洲设有研发中心，在香港、新加坡和马来西亚设有分支机构，全球员工近4000名。
    绿叶制药致力于创新药物的研发、生产和销售，30余个上市产品覆盖中枢神经系统、抗肿瘤、心血管、消化及代谢等规模最大及增长速度最快的治疗领域；业务遍及中国、美国、欧洲、澳洲、日韩等全球主要医药市场及新兴市场。绿叶制药建立了与国际接轨的研发体系，在微球、脂质体、透皮释药和皮下植入剂等新型给药系统领域处于国际先进水平。公司拥有丰富的在研产品线，多个创新制剂及创新药在美国FDA开展不同阶段的注册临床研究，并已取得突破性进展。
    绿叶制药将继续以创新和国际化为方向，力争成为最受尊敬的全球领先制药企业。

使命：专业技术服务于人类健康
愿景：成为最受尊敬的全球领先制药企业
核心价值观：诚信、合作、创新、卓越

公司以“成就员工”作为公司的经营理念，把员工视为绿叶最宝贵的财富：
人力资源政策：采取积极主动的人力资源政策，吸引、保留海内外优秀人才
多通道职业发展：建立多通道职业发展路径，充分发挥员工潜力，实现员工与公司的可持续发展
绿叶常青学院：成立面向员工的企业内部大学——绿叶常青学院，培养后备管理人才
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