职位描述
* Support digital use cases as Quality SME combined quality professional and digital capability to ensure compliance to PQS, cGMP and regulation interfacing between QA/compliance and digital operation. * Support development of GPQS, ECMS, GVLMS，SAP database and provide oversight and expertise. * Leading/implement site quality digital transformation plan, uplifting organization digital capability. * Introduce/implement/support digital use case to achieve the quality improvement. * Support the daily affairs of quality-related systems. Promote the integration and optimization of systems and related business processes. * Improve the visualization of quality business, develop data analysis capabilities. Provide support for different quality tiers to make decisions based on data. * Build the innovation culture and improve the digital ability of Quality Assurance Function. * Manage QAF’s digital applications to support daily business. * 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. * Conduct activities and interactions consistent with Company Values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role (including SHE). Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-complianceEducation, Qualifications, Skills and ExperienceEssential * Bachelor’s degree and general experience in pharmaceutical quality, manufacturing, or technical roles. * 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. * Have computerized system related working experience * A basic knowledge of computer validation requirements and 21 CFR 11 requirements. * Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional. * Use both Chinese and English as working language. * Excellent oral and written communication skills with the ability to communicate effectively with individuals from all levels of the organization.Desirable * Experience within a complex dynamic business environment * Device manufacturing/quality supervisory/management experience * Lean / six sigma manufacturing training and applied experience * In-depth experience with project management * Embracing change and innovation and actively seek ways to simplify and standardize across the Quality network
