External Quality Specialist

Description

Job Summary: Pharmaceutical professional to lead the BPA Management System, manage regulatory affairs, and ensure regulatory compliance for medical devices. Key Responsibilities: 1. Leadership of the BPA Management System and pharmacy operations 2. Comprehensive management of logistics operators and audits 3. Management of sanitary registrations and regulatory compliance **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 registrations for medical devices. * Experience in audits, CAPA, and Quality Management Systems. * Familiarity with ISO 13485 and current sanitary regulations. * Proficiency in Excel and intermediate English. **RESPONSIBILITIES:** * Leadership of the BPA Management System for national pharmacy operations and importation. * Comprehensive management of logistics operators (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 for medical devices. * Monitoring and analysis of regulatory changes impacting the business. * Administration of sanitary 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: Starting from S/.1\.00 per month Application Questions: * Are you a licensed and registered Pharmaceutical Chemist with at least 3 years of experience in quality and/or regulatory affairs within the health sector? * Have you served as Technical Director or Pharmacy Regent? * What is your experience in Good Storage Practices (BPA) and distribution? * What has been your involvement in managing and maintaining sanitary registrations with DIGEMID? * Are you available to work onsite three times per week, three hours per day, in Trujillo? * What is your gross monthly salary expectation? * What is your level of English? Work Location: Onsite employment