Validation Manager

Description

Position Summary: Responsible for planning, directing, and controlling qualification and validation activities in the pharmaceutical industry to ensure regulatory compliance. Key Highlights: 1. Leadership in validation of critical processes, equipment, and systems. 2. Participation in strategic quality and compliance projects. 3. Professional development and continuous training. ***IMPORTANT: A PHARMACEUTICAL COMPANY IS CURRENTLY SEEKING A VALIDATION MANAGER!!!*** The incumbent will be responsible for planning, directing, and controlling qualification and validation activities for processes, equipment, critical systems, cleaning, facilities, and computerized systems, ensuring compliance with Good Manufacturing Practices (GMP), regulatory requirements, and Quality Management System standards, thereby guaranteeing that manufacturing processes are reproducible, reliable, and maintained in a validated state. Main Responsibilities: * Manage validation of manufacturing, packaging, and cleaning processes for products manufactured by the company. * Develop the Validation Master Plan, as well as qualification and validation protocols, schedules, and reports for equipment, facilities, critical systems, processes, cleaning, and computerized systems. * Coordinate with various departments the execution of qualification, validation, and calibration activities in accordance with approved protocols and procedures. * Report progress of programs established in the Validation Master Plan to Technical Management, Quality Assurance, and Management. * Participate in the evaluation and selection of suppliers providing calibration, qualification, and validation services, as well as in the technical review of contracts. * Provide technical support during technology transfer processes and implementation of new industrial processes. * Prepare and manage the annual budget for the Validation Department. * Train personnel involved in validation and qualification activities, promoting adherence to GMP and internal procedures. * Lead and supervise the Validation Team, monitoring activity execution, protocol compliance, and recording of critical parameters, deviations, and non-conformities. * Investigate root causes of deviations occurring during validation activities and coordinate implementation of corrective and preventive actions (CAPA). * Analyze data obtained during validations and prepare corresponding technical reports. * Actively participate in technical and quality committees, proposing continuous improvement initiatives. * Ensure proper custody and traceability of documentation generated during qualification and validation processes. * Define and monitor work plans and the annual validation program. * Conduct on-site follow-up during execution of qualifications, standardizations, and validations, verifying compliance with approved protocols. * Maintain updated procedures, protocols, forms, and technical documentation for the department. * Manage the technical archive for analytical validations, qualifications, and related documentation. * Chair the Qualification and Validation Committee, promoting achievement of the company's validation program objectives. Required Profile: **Academic Background** * Degree in Pharmaceutical Chemistry, Industrial Chemistry, Chemical Engineering, Industrial Engineering, or related fields. **Experience** * Minimum three (3) years leading validation, qualification, and/or quality assurance processes. * Experience managing personnel and leading technical teams. * Specialization in Quality Management, Validation, Pharmaceutical Production, or related areas (desirable). **Technical Knowledge** * Good Manufacturing Practices (GMP). * Validation of processes, cleaning, computerized systems, and analytical methods. * Qualification of equipment and infrastructure. * Critical systems (HVAC, purified water, compressed air, among others). * Quality risk management. * Deviation investigation, root cause analysis, and CAPA. * Applicable Colombian pharmaceutical regulations and regulatory reporting. * Management indicator handling and budget preparation. Competencies: * Leadership. * Planning and organization. * Decision-making. * Analytical thinking. * Results orientation. * Effective communication. * Teamwork. * Negotiation and influence. * Change management. * High sense of responsibility and professional ethics. We Offer: * Direct employment with the company. * Job stability. * Professional development and continuous training. * Participation in strategic quality and regulatory compliance projects. * Competitive salary commensurate with experience. Work Location: On-site position