کارشناس تضمین کیفی و رگولاتوری

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. - Create and manage control dashboard with all the inter department regulatory requirement for product compliance, with relevant work instructions, support the strategy to increase time and accuracy product regulatory compliance. Establish and maintain system for tracking changes in documents submitted to regulatory authorities or partners. - Assist in improvement in the quality system and development - Quality Risk Management - Guidelines and protocols to prepare reports, SOPs and all the required documents - Identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; preparing quality documentation and reports , by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations monitoring inventories and distributor companies, develop quality assurance plans by conducting hazard analyses; - Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures; - Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; - Support in providing and execution of CTD - 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 - Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws - Help the company or organization meet local, international, and industrial regulations that apply to their products, support in collecting and coordinate information and prepare regulatory documentation for submission to regulatory experts or to commercial partners, - Support and coordinate in regulatory issues and dissemination regulatory information to Production, QA, QC, Supply departments Support maintenance of regulatory files in compliance with local and international regulation, guidance and standards applicable to company products - Ensures QA compliance of products with the current regulations in country - Ensure that the content, organization and overall quality of all regulatory documents and samples are adequate and complies with local regulatory requirements, commitments and agreements. - Maintain database with information on national regulatory requirements continuously update and advise of any changes in regulations