Quality Assurance Director. This individual will be responsible for Quality Operations which include Quality Assurance, Quality Compliance and Validation programs, ensuring compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and other regulations as applicable (such as WHO, EMA and USFDA).

QA Director Responsibilities:
•Implementing and managing the GMP Quality System in collaboration with Research and Development, Manufacturing, QA and QC, Engineering.
•Ensuring the company’s clinical trials supplies production is carried out in accordance with company policies and government regulations
•Directing the internal and external GMP audit program to support business and regulatory requirements
•Developing and implementing a system to manage change control, OOS’s, deviations and product complaints
•Approving batch manufacturing records and analytical methods
•Authorizing release of commercial and clinical trial supplies
•Developing and managing a system which ensures the company’s documentation is complete, monitored, accurate and current, Documentation will include: Specifications, Validation protocols, test ****s & reports, Analytical Methods, Formulation Reports, Stability Protocols and Reports, labeling, Technical and Clinical Study reports, etc.
•Assuring appropriate standards are applied to conduct facility and equipment, cleaning, process validation and method validation activities
•Hosting and coordinating all aspects of FDA (and other regulatory bodies) inspections/audits. Effectively leading and managing a productive and respected QA team
•Ensuring new CMOs are assessed for GMP compliance and certified prior to supply of services and or goods
•Supporting GMP training and technical training initiatives. Contributing towards building a Quality mindset throughout the organization

2009年注册，注册资金1098.9万元，专业从事疫苗的研发和生产。创业和管理团队拥有国际领先的疫苗研发生产技术和项目执行管理经验，掌握疫苗研发的多项专有技术，截止目前公司完成了4项国内发明专利的申请，还有6项发明专利正在申报。公司自主研发产品中四价流脑结合疫苗、组分百白破疫苗可填补国内空白，并且保护性好、生产成本低，康希诺拥有核心技术能够在国内完成新产品的开发和已有产品的质量和技术升级。