Overview
Associate Director Quality Digital Jobs in Taizhou, Jiangsu, China at AstraZeneca
Title: Associate Director Quality Digital
Company: AstraZeneca
Location: Taizhou, Jiangsu, China
Job Description
- Leading the digital & automation strategy applied in GMP area
- 领导数字化战略在 GMP 领域的应用
- Leading/Implement site quality digital transformation plan and QC automation program, uplifting quality organization digital capability and deliver a competitive advantage to quality business
- 领导/实施工厂质量团队的数字化转型计划，提升质量团队的数字化能力，并为业务创造竞争性优势
- Introduce/implement/support digital solution and QC automation solution to achieve the quality improvement area identified.
- 引入/实施/支持数字解决方案以实现在质量领域的改进
- Support digital use cases as Quality SME combined quality professional and digital capability to ensure compliance to PQS, cGMP and regulation interfacing between Quality/compliance and digital operation.
- 作为质量团队专家，支持各类数字化解决方案，结合质量专业和数字能力，以确保在同时涉及数字化与质量/合规两方面的业务中，符合 PQS、cGMP 等法规要求
- Define site quality improvement which are enabled by digital technologies.
- 利用数字化技术推动工厂的质量提升
- Leading/implement site quality digital transformation strategy and plan, uplifting organization digital capability
- 领导/实施工厂质量团队的数字化转型计划，提升质量团队的数字化能力
- Introduce/implement/support digital use case to achieve the quality improvement.
- 引入/实施/支持数字解决方案以实现在质量领域的改进
- Support the daily affairs of quality-related systems, promote the integration and optimization of systems and related business processes.
- 支持质量相关系统的日常事务，推动系统与相关业务的整合优化
- Improve the visualization of quality business, develop data analysis capabilities, provide support for different quality tiers to make decisions based on data.
- 提升质量业务的可视化水平，开发数据分析能力，为各层级基于数据制定质量决策提供支持
- Build the innovation culture and improve the digital ability of Quality Assurance Function.
- 打造创新文化，提升质量保证团队的数字化能力
- Act as business Quality partner with IT
- 作为IT团队的质量合作伙伴
- Manage Quality Function digital applications to support daily business.
- 管理质量职能团队的数字化应用以支持日常业务
- Take the role as QA business partner to support Digital Uplift in Taizhou Site.
- 作为质量合作伙伴支持泰州工厂的数字化提升项目
- Participate in the develop of quality management strategy for new technology.
- Ensure the projects delivering and related validation activities meet the requirements of GMP regulations and quality requirements.
- 参与制定新技术的质量管理战略。确保项目交付及相关验证活动符合GMP法规和质量要求
- Act as a conduit to take direction from Ops Quality to site in delivering Digital Strategy
- 在交付数字战略的过程中，确保运营质量团队与工厂之间的沟通渠道
Education, Qualifications, Skills, And Experience
- Bachelor’s degree and general experience in pharmaceutical quality, manufacturing, or technical roles.
- 本科及以上学历，具有制药质量、生产制造或技术相关岗位工作经验
- A good knowledge of cGMPs and global GMP requirements, quality systems, and pharmaceutical product/device testing technology and pharmacopeia. Well -developed interpersonal and problem-solving skills.
- 熟悉 cGMP 及全球 GMP 要求，了解质量管理体系、药品/医疗器械检测技术及药典相关要求，具备良好的人际沟通能力和问题解决能力
- Have computerized system related working experience
- 具备计算机化系统相关工作经验
- A basic knowledge of computer validation requirements.
- 了解计算机化系统验证要求
- Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional.
- 具备独立工作能力，同时能够在跨学科、跨职能团队环境中高效协作
- Use both Chinese and English as working language.
- 能够熟练使用中英文作为工作语言
- Excellent oral and written communication skills with the ability to communicate effectively with individuals from all levels of the organization.
- 具备优秀的口头及书面沟通能力，能够与组织内不同层级人员进行有效沟通
