苏州招聘

Duties
Manages and executes the qualification and validation of equipment, infrastructure (e.g. utilities and support systems) and software to assure quality and stability prior to deployment in commercial environments
Ensures appropriate regulations, guidelines and company policies are followed and applied during all stages of project activities
Responsible for deliverables such as system assessments, validation (e.g., DQ, IQ, OQ, PQ) protocols, commissioning plans, commissioning and validation summary reports, etc., for new functionality, enhancements, changes, maintenance releases, and periodic revalidation
Works with cross-functional teams (e.g. Operations, QA, and Project Management) to evaluate and establish testing milestone and criteria to ensure projects are on schedule and meet quality compliance
Identifies and coordinates activities and tasks required to complete qualification and validation activities including reviews with QA, obtaining signature approvals, executing plans and protocols
Provides training and mentoring related to all aspects of the job to new colleagues
Assists in resolving and documenting technical and project-related issues
Background
3+ years of experience in a regulated environment
Experience in biotech, pharma, and/or medical device is preferred
Bachelor’s degree in a Life Science, Engineering, or related discipline or comparable experience
English reading and writing ability
Technical writing, verbal communication, interpersonal and problem solving skills
Proficient in testing principles, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends is preferred
Expertise in interpretation of applicable regulations and industry guidance documents used in GxP environments is preferred
Ability to assemble, analyze and evaluate data and able to make appropriate recommendations and decisions
Commitment to quality
Able to manage multiple tasks and work independently
Able to manage schedule and budget
Must be customer focused and a team player; experience working with global team is a plus

药明康德是国际领先的开放式能力与技术平台公司，为全球制药及医疗器械等领域提供从药物发现、开发到市场化的全方位一体化的实验室研发和生产服务。本着以研究为首任，以客户为中心的宗旨，药明康德通过高性价比、高效率的服务平台帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。药明康德平台涵括化学药研发和生产、细胞及基因疗法研发生产、药物研发和医疗器械测试等，正承载着来自全球30多个国家的3500多家创新合作伙伴的数千个研发创新项目，致力于将最新和***的医药和健康产品带给全球病患，实现“让天下没有难做的药，难治的病”的梦想。