QUALIFICATION ANALYST

Description

Job Summary: The Qualification Analyst will ensure the reliable and secure operation of computerized production equipment by managing audits, backups, user administration, and operational cybersecurity. Key Highlights: 1. Opportunity to make an impact, grow, and learn within a leading international company. 2. Be part of a company recognized for its culture and diversity. 3. Comprehensive management of audits, backups, and operational cybersecurity (OT). **QUALIFICATION ANALYST** **About Abbott** Abbott is a global healthcare leader, creating innovative science to improve people’s health. We are always looking ahead, anticipating changes in medical science and technology. **Working at Abbott** At Abbott, you can do work that matters, grow and learn, take care of yourself and your family, be authentically you, and live a full life. You’ll have access to: * Professional development with an international company where you can build the career you’ve always dreamed of. * A company recognized as a top workplace in dozens of countries worldwide and named one of the world’s most admired companies by Fortune magazine. * A company recognized as one of the best large employers for working mothers, women executives and scientists, and one that values diversity. **The Opportunity** This position is located in Cali within the Established Pharmaceuticals Division. We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality, branded generic medicines spans multiple therapeutic areas, including gastroenterology, women’s health, cardiometabolic, pain management / central nervous system, and respiratory. As a Qualification Analyst, you will ensure the reliable, secure, and regulatory-compliant operation of computerized production equipment through comprehensive management of electronic audits, data backups, user administration, operational cybersecurity (OT), preventive and predictive maintenance plans, and associated technical documentation. **What You’ll Do** * Support the Validation Coordinator in developing overall work plans based on guidelines established in the Validation Master Plan, manuals, and related procedures. * Collaborate with the Validation Coordinator to develop activity schedules using information provided by Research & Development, Planning, Production, Regulatory Affairs, and Management Guidelines. * Collaborate with the Validation Coordinator to maintain up-to-date manuals, procedures, instructions, and forms applicable to qualification and validation processes, aligned with company needs. * Analyze and implement improvements to existing processes, including corresponding procedures, guidelines, and forms. * Define process metrics for validation and qualification projects and conduct such measurements. * Conduct audits and inspections of processes and identify opportunities for improvement. * Establish, together with the Validation Coordinator, tracking tools for completed activities as indicators of progress for validation programs. * Coordinate with the Validation Coordinator and Development, Planning, and Production teams to schedule critical support equipment and systems required for validation program activities. * Collect information related to each unit operation of the processes under validation monitoring. * Document and tabulate results from various tests conducted. * Coordinate and participate in the various activities outlined in the individual validation plan with process leaders. * Standardize and promulgate documents used and generated during process validation development. **Required Qualifications** * Electronic Engineering, Industrial Engineering, or related field * Minimum 6 months of experience **Preferred Qualifications** * Office (Word, Excel, PowerPoint) / SAP * Knowledge of quality indicator management * Understanding of industrial production equipment operation * Concepts of preventive, corrective, and predictive maintenance **PERSONS WITH DISABILITIES** Equal opportunity is provided, and recruitment, selection, and hiring are conducted solely based on job-related qualifications, without distinction due to race, color, religion, creed, age, sex, nationality, gender identity or expression, sexual orientation, disability, marital status, veteran or military status, genetics, citizenship status, or any other condition protected by law. The Job Position Assessment Report for Persons with Disabilities, prepared by the EHS department, will be considered for personnel placement. Apply Now Pursue your professional aspirations with Abbott to access diverse opportunities at a company that can help you build your future and live your best life. Abbott is an equal opportunity employer committed to workforce diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews and @AbbottGlobal.