Descrição do Perfil

MAIN RESPONSIBILITIES: SUPPORT DEVIATION INVESTIGATIONS AND IMPLEMENTATION OF CAPA (CORRECTIVE AND PREVENTIVE ACTIONS) COORDINATE WITH DEPARTMENT MANAGERS TO ENSURE EFFECTIVE CAPA EXECUTION ASSIST IN QUALITY IMPROVEMENT AND PROBLEM-SOLVING INITIATIVES MANAGE CUSTOMER COMPLAINTS, INVESTIGATIONS, AND FOLLOW-UP ACTIONS REVIEW ANALYTICAL METHODS AND SPECIFICATIONS FOR REGULATORY COMPLIANCE REVIEW AND DISTRIBUTE PRODUCT APPROVAL PACKAGES (PAP) REVIEW AND APPROVE PACKAGING ARTWORK AND PRINTED MATERIALS MAINTAIN PRODUCT AND BUSINESS PARTNER MASTER DATA IN ORACLE MANAGE SUPPLIER QUALIFICATION, AUDITS, CERTIFICATIONS, AND LICENSING VERIFICATION MAINTAIN QUALITY TECHNICAL AGREEMENTS AND SERVICE AGREEMENTS OVERSEE MANUFACTURER CHANGE CONTROL PROCESSES AND REGULATORY UPDATES MONITOR CAPA EFFECTIVENESS AND CONTINUOUS IMPROVEMENT ACTIVITIES REVIEW AND PROCESS INTERNAL CHANGE CONTROLS AND CHANGE REQUESTS SUPPORT VALIDATION ACTIVITIES FOR EQUIPMENT, SYSTEMS, AND PROCESSES COORDINATE TESTING, AUDIT TRAIL REVIEWS, AND VALIDATION COMPLIANCE CONTROL, DISTRIBUTE, AND MAINTAIN QUALITY DOCUMENTATION AND RECORDS CONDUCT GMP COMPLIANCE AUDITS THROUGH SELF-INSPECTION PROGRAMS DELIVER GMP AND QUALITY-RELATED TRAINING TO EMPLOYEES COMPILE AND REVIEW PRODUCT QUALITY REVIEWS (PQRS) PREPARE QUALITY DEVIATION REPORTS AND ENSURE TRACEABILITY OF FINDINGS ENSURE DATA INTEGRITY COMPLIANCE FOR GMP-RELATED SOFTWARE SYSTEMS REVIEW PROTOCOLS AND REPORTS FROM INTERNAL AND EXTERNAL STAKEHOLDERS PERFORM RISK ASSESSMENTS AND DEFINE CORRECTIVE ACTIONS FOR HIGH-RISK EQUIPMENT MAINTAIN PRODUCT MARKETING AUTHORISATIONS PARTICIPATE IN SUPPLIER AND MANUFACTURER QUALITY AUDITS SUPPORT REGULATORY INSPECTIONS AND CUSTOMER AUDITS REQUIRED PROFILE:BACHELORS DEGREE IN PHARMACY, CHEMISTRY, BIOLOGY, OR RELATED SCIENTIFIC FIELD. MINIMUM 1¿3 YEARS¿ EXPERIENCE IN A PHARMACEUTICAL QA ENVIRONMENT (PREFERRED). STRONG UNDERSTANDING OF GMP, GDP, AND REGULATORY GUIDELINES (FDA, EMA, WHO). ANALYTICAL, PROBLEM-SOLVING AND COMMUNICATION ABILITIES