#LI#Buenos Aires

As a Digital Quality Control Specialist, you will play a crucial role in our pharmaceutical company, supervising the implementation of Labware (GLIMS) in three Quality Control (QC) labs within the region. Your expertise in digital quality control systems, specifically GLIMS, will ensure the successful integration and utilization of Labware across these labs, ultimately supporting the improvement of our quality control processes.

Responsibilities:

•Lead the implementation and management of Labware (GLIMS), a global laboratory information management system, within three QC labs in the region, ensuring seamless integration and effective utilization of the system. Collaborate with cross-functional teams, including IT, QC, and lab personnel, to gather requirements, design workflows, and configure Labware (GLIMS) to meet the specific needs of each lab.
• Customize Labware (GLIMS) functionalities and workflows to streamline quality control processes, automate data management, and ensure regulatory compliance.
• Conduct detailed testing and validation of Labware (GLIMS) functionalities to ensure accuracy, compliance, and data integrity.
• Develop and maintain standard operating procedures (SOPs) for Labware (GLIMS) usage, ensuring that all lab personnel are trained on the system and implement to established protocols.
• Provide ongoing technical support and troubleshooting for Labware (GLIMS) users, addressing any issues or concerns promptly and reliably. Supervise and analyze data generated by Labware (GLIMS), identifying trends and potential areas for improvement in quality control processes.
• Collaborate with the Quality Assurance (Deviation handling .,CAPA definition,KPI trending -data integrity review and approval of analytical data / tests (analytical release) Stability testing (Projects) protocol preparation, evaluation, report preparation . -Reporting (Stability plan preparation, trend analysis, evaluation) Review and approval of analytical tests (analytical release) Microbiological QC Perform Microbiological testing of materials and utilities, environmental and personnel supervising .Provide expert Support for site qualification and validation activities. Maintain and calibrate equipment incl. plan preparation.
• Stay updated with the latest advancements in digital quality control systems, specifically Labware (GLIMS), and recommend improvements or additional tools to improve efficiency and effectiveness.