Job Description :Job SummaryThe QA Specialist Change Control and Risk Management Specialist for the Quality Support Center (QSC) assists with the creation and maintenance of change controls and Quality Risk Management programs in alignment with application Healthcare regulations (e.g., cGMP, GDP, GMP) and ISO 9001/ISO 13485 requirements.Additionally, he/she is responsible for the creation of reports and follow up on open items related to applicable change controls and/or risk records.In this role, he/she will provide support the field Quality team by coordinating change control and/or quality risk management activities, as applicable, communicate risk concerns identified to the next level of management.Other DutiesSupport his/her management with the coordination of tasks, design, impact, and/or continuous improvement of the Change Control and Risk Management Programs.Initiates, assesses, and documents change controls and risk records (if applicable) within in the electronic Quality Management System (eQMS).Follow up with internal and external stakeholders on all open items related to change controls or risk records within in the eQMS.Escalates risks, presents risk assessment report, and makes recommendations to the next level of management.Tracks action plans to closure and reports late/delayed action plans to the next level of management.Provides data and supports quality management system reviews for area(s) of responsibilities.Preferred CompetenciesExperience with healthcare regulations (e.g., cGMP, GDP, GMP) guidelines is preferred.Experience with ISO 9001 and ISO 13485 standards is an advantage.English advancedKnowledge of Quality Management System is an advantage.Knowledge of Microsoft Office (Excel, Word, Outlook, Access).Captures/documents specific and accurate information; learns subjects thoroughly and in detail; completes work with thoroughness; supplies appropriate details when requested; maintains organized files.Identify potential gaps in the processes and make recommendations for possible improvements.Strong time management skill, able to work within time-limits (deadlines).MINIMUM QUALIFICATIONSBachelor's Degree (or internationally comparable degree) – PreferredBachelor's Degree (or internationally comparable degree) – Science or related discipline – PreferredGrade: 10CLocation: BogotaDeadline to apply: Monday 17th June, 2024.Employee Type: PermanentUPS is committed to providing a workplace free of discrimination, harassment, and retaliation.
