锦鲤求职岗位描述
在罗氏，我们鼓励每位同事展现真实的自己；我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结，在这里，你将因为做自己而被重视、接纳和尊重，并得到个人的提升和职业的发展。所有的这一切，都是为了更好地预防、阻止和治愈疾病，并确保医疗资源的可及性和可持续性。欢迎加入罗氏，一个重视每种声音的地方。
职位
Quality and Technical Guidance
● Oversee programs to support Visual Inspection Operations at the Drug Product facility.
● Execute daily operations, including but limited to:
○ Providing Quality Oversight and guidance during on-the-floor manufacturing, QC, warehouse or GMP utility & facility
○ Executing daily on-the-floor duties to ensure facilities, equipment, materials, operations and documentation comply with SOPs and safety standards.
○ Performing Quarantine and Segregation of materials.
○ Performing line clearances activities.
○ Perform Acceptable Quality Level (AQL) visual inspection.
● Review documents and records, including but not limited to batch production records, batch testing records, data sheets and protocols.
● Ensure that the records and data are complete, accurate, and documented according to the written procedure.
● Author/Review/Approve Quality documents, such as Standard Operating Procedures (SOP’s), Risk Assessment (RA), training materials, training documents, protocols and reports.
● Support and represent QA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
● Identification and implementation of continuous improvement opportunities within QA processes and systems and contribute to the continuous improvement of culture.
● Maintain project timelines associated with initiatives to support the evolving business.
● Responsible for ensuring that product quality events are correctly investigated, and that appropriate corrective and preventative actions are implemented. Review deviation/exception/ investigation / /OOS&OOE&OOT reports.
● Supports management to implement and maintain the following programs: Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Roche Global document assessments required to be performed at the site level.
● Participate in tech transfer, collaboration with other functions to ensure the success of new product manufacturing.
Support the compliance, regulatory and training activities, other related duties as required
我们是谁
打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。
让我们一起，构建更健康的未来。
罗氏提供平等的职业发展机会。