کارشناس سیستم ها و روش ها

Job Description

•Professional at preparing and completing Quality documentation, meet professional QA objectives provide reports on a regular basis, and have experience in self-inspections internal and external audits •Technical knowledge in the framework of quality assurance activities, to develop and implement quality assurance protocols and standard operating procedures •Development, periodic review, revision and implementation of SOPs and other documents needed in different Processes. Actively assists in investigations process and define optimize process work. • Effectively following priorities in order to implement corrective and preventive actions •Quality Risk Management •Correctly applies CAPAs or change management. •Participate in corporate meetings to support strategies, for meeting changing regulatory requirements and driving projects across the operations to implement required changes efficiently and effectively •Appropriately applies principles of continuous improvement. •Approves and ensures implementation of standardized operating procedures. •Approves documents according to templates and required GMPs, ISO IMS, … •Accurately assesses audit findings •Provides inspectors with clear and comprehensive files (external audits). •Responds with proficiency to questions from inspectors (external and internal audits). •Actively engaged in the follow-up of audit observations. •Periodic GMP training for relevant staff •Analyze, monitor, and ensure that the organization processes comply with international standards • liaising with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations