Quality Specialist

Description

Position Summary: Pharmaceutical professional to lead the GSP Management System, manage logistics operators, and ensure regulatory compliance for medical devices. Key Highlights: 1. Leadership in Good Storage Practices (GSP) management 2. Comprehensive management of logistics operators and audits 3. Ensuring regulatory compliance and health surveillance **REQUIREMENTS:** * Licensed and registered Pharmaceutical Chemist. * Minimum 3 years of experience in Quality and Regulatory Affairs. * Experience in Good Storage, Distribution, and Transportation Practices. * Knowledge of VUCE and sanitary registration of medical devices. * Experience in audits, CAPA, and Quality Management Systems. * Familiarity with ISO 13485 and current health regulations. * Proficiency in Excel and intermediate English. **RESPONSIBILITIES:** * Leading the GSP Management System for pharmacy and import operations nationwide. * Comprehensive management of third-party logistics providers (3PL), audits, and KPI monitoring. * Supervision of cold chain and storage conditions in accordance with regulatory requirements. * Management of deviations, non-conformities, and CAPA plans. * Review and release of imported products, ensuring documentary, sanitary, and labeling compliance. * Coordination of equipment calibration and maintenance programs. * Management of sanitary registrations, renewals, and modifications of medical devices. * Monitoring and analysis of regulatory changes impacting the business. * Administration of health surveillance and technovigilance activities. * Verification of regulatory compliance for labels, packaging, and product information. * Regulatory document management and support to the Quality Management System (QMS). Salary: Up to S/.3\.00 per month Application Question(s): * Are you a licensed and registered Pharmaceutical Chemist with at least 3 years of experience in quality and/or regulatory affairs within the healthcare sector? * Have you served as Technical Director or Pharmacy Manager? * What experience do you have in Good Storage Practices (GSP) and distribution? * Do you have experience conducting procedures via the VUCE platform? What types of procedures have you handled? * What has been your involvement in managing and maintaining sanitary registrations with DIGEMID? * Are you available to work on-site in Lima? * What is your level of English proficiency? * What is your gross monthly salary expectation? Work Location: On-site employment