Validation Coordinator

Description

Position Summary: Coordinate and supervise qualification and validation activities to ensure maintenance of the validated state, compliance with Good Manufacturing Practices (GMP) and regulatory requirements in the pharmaceutical industry. Key Highlights: 1. Coordination and supervision of pharmaceutical validations. 2. Quality management and regulatory compliance in pharmacy. 3. Technical leadership in validation projects. ***IMPORTANT: PHARMACEUTICAL LABORATORY IS SEEKING A VALIDATION COORDINATOR!!!*** Coordinate, execute, and supervise qualification and validation activities for processes, equipment, critical systems, cleaning, analytical methods, and computerized systems, ensuring maintenance of the company's process validated state, compliance with Good Manufacturing Practices (GMP), regulatory requirements, and Quality Management System guidelines. Main Responsibilities * Coordinate and supervise validation of manufacturing, packaging, and cleaning processes for products manufactured by the company. * Develop, execute, and manage qualification and validation programs, schedules, and protocols for equipment, facilities, critical systems (HVAC, purified water, compressed air, chilled water, and clean steam), processes, cleaning, and computerized systems. * Supervise that validation, qualification, and calibration activities are performed in accordance with protocols, approved procedures, and established schedules. * Periodically report progress of the Validation Master Plan and execution programs to the Validation Head and Quality Assurance. * Participate in technical review of contracts and monitoring of service providers for calibration, qualification, and validation. * Maintain up-to-date master lists, procedures, protocols, forms, and other technical documentation of the area. * Manage availability of equipment, materials, and supplies required for validation activities. * Supervise and guide Validation personnel activities, ensuring compliance with procedures and area objectives. * Train personnel involved in validation and qualification processes on test methodology and protocol requirements. * Coordinate execution of validation tests with Production, Quality Control, Engineering, Maintenance, and Quality Assurance departments. * Conduct on-site follow-up during validation activities, verifying recording of critical parameters, protocol compliance, and proper documentation of activities. * Identify, document, and manage deviations, exceptions, and non-conformities arising during validation execution. * Investigate root causes of deviations, implement corrective and preventive actions (CAPA), and verify their effectiveness. * Analyze information obtained during validations and prepare corresponding technical reports. * Present and communicate validation results to the Validation Committee and involved departments. * Safeguard and ensure integrity, traceability, and confidentiality of technical documentation generated by the area. * Develop validation work plans and annual validation schedules, continuously tracking their implementation. * Ensure execution of Production and Quality Control equipment qualifications, as well as maintenance of the validated state of processes. * Ensure compliance with maintenance, calibration, and qualification programs for equipment under the area’s responsibility. * Verify availability of required analytical methods for validation execution. * Promptly report any deviation related to maintenance of facilities, installations, or equipment that may affect the validated state of processes. * Promote continuous improvement of validation processes and compliance with regulatory and quality standards. Required Profile Academic Background * Pharmaceutical Engineering, Pharmaceutical Chemistry, or Process Engineering. * Specialization in Validation, Quality Management, Pharmaceutical Production, or related fields (desirable). Experience * Minimum three (3) years of experience in validations and qualifications within the pharmaceutical industry. * Experience coordinating technical teams and validation projects. * Experience in regulatory audits and maintenance of the validated state. Technical Knowledge * Good Manufacturing Practices (GMP). * Validation Master Plan. * Process, cleaning, analytical method, and computerized system validation. * DQ, IQ, OQ, and PQ qualification. * Critical systems (HVAC, purified water, compressed air, chilled water, and clean steam). * Quality risk management. * Deviation investigation, root cause analysis, and CAPA. * Colombian pharmaceutical regulations and applicable international standards. * Management indicator handling and office software tools. Competencies * Leadership. * Planning and organization. * Analytical thinking. * Results orientation. * Effective communication. * Teamwork. * Decision-making. * Attention to detail. * Proactivity. * Commitment to quality and continuous improvement. We Offer * Direct employment contract with the company. * Job stability. * Professional development and continuous training. * Competitive salary commensurate with experience. Work Location: On-site employment