Senior QC LIMS Technician Hay Level 15 (C4)

KEY PERFORMANCE AREAS PRINCIPAL ACCOUNTABILITIES SYSTEM SUPPORT AND MAINTENANCE * Serve as the primary administrator for Quality Control LIMS. * Configure, maintain, and manage LIMS master data, including specifications, products, materials, test methods, stability studies, users, and laboratory workflow. * Perform system updates, configurations, and routine maintenance to ensure optimal performance. * Ensure the LIMS remains compliant with cGMP, ALCOA+ data integrity principles, and applicable computerized system regulations. * Coordinate LIMS upgrades, patches, enhancements, and new functionality with Information Technology and software vendors. * Perform system administration activities including user account management, security roles, permissions, and audit trail reviews. * Lead and support computerized system validation activities, including preparation and execution of validation documentation URS, Risk Assessments, IQ/OQ/PQ, Test Scripts and Validation Reports. * Provide day-to-day technical support and investigate and resolve LIMS-related incidents, deviations, and technical issues. USER SUPPORT AND TRAINING * Develop, review, and maintain SOPs, work instructions, and training material relating to LIMS. * Provide end-user training and technical support to laboratory personnel. * Continuously assist laboratory staff in navigating and using the LIMS effectively. * Respond to user requests and resolve queries promptly. DATA MANAGEMENT * Ensure the accuracy, integrity, and security of data within the LIMS. * Manage data entry, import/export processes, and system-generated reports. * Monitor data workflows to ensure compliance with regulatory requirements e.g., GLP, cGMP, ISO standards. * Ensure that all laboratory equipment is interfaced with the LIMS. SYSTEM DEVELOPMENT AND OPTIMIZATION * Collaborate with laboratory and IT teams to identify opportunities for system improvements. * Assist in the testing and implementation of LIMS updates and new features. * Customize system configurations to align with laboratory requirements. DOCUMENTATION AND REPORTING * Support Change Control, CAPA, and audit activities related to laboratory computerized systems. * Maintain detailed records of system changes, issues, and resolutions. * Generate routine and ad hoc reports for laboratory management. * Document system processes, procedures, and workflows for internal use. GOVERNANCE, RISK & COMPLIANCE * Pharmaceutical standards and compliance requirements regarding equipment as well as knowledge of 21CFR compliance. * Provide input to QC Department for improvement compliance systems on equipment using the LIMS system. * Liaise with the approved supplier and IT for maintenance of LIMS system. * Coordinate and initiate risk/ impact assessments and plans to address LIMS deficiencies. KNOWLEDGE AND SKILLS: Skills and Competencies * Familiarity with LIMS platforms and their application in laboratory workflows. * Proficiency in database management and data analysis tools. * Strong problem-solving and troubleshooting abilities. * Excellent attention to detail and organizational skills. * Ability to work collaboratively in a cross-functional team environment. * Knowledge of regulatory compliance standards e.g., GLP, cGMP, ISO is a plus. Technical Proficiencies * Experience with SQL, database systems, or similar tools is advantageous. * Familiarity with programming languages e.g., Python, JavaScript is a bonus. * Proficiency in Microsoft Office Suite Word, Excel, PowerPoint. Requirements QUALIFICATIONS AND EXPERIENCE * B Tech / Bachelor’s degree in Chemistry, Biology, Information Systems, or a related field. * Minimum of 5 years experience experience administering or supporting a Laboratory Information Management System LIMS. * Experience with computerized system validation. * Experience with laboratory instrument integration and master data management. * Knowledgeable on cGMP/PIC’s regulations/guidelines related to laboratory software. * Previous experience with Change Control, Deviations, CAPA, and audit support. Must be medically fit to qualify as a radiation and chemical worker. * Must be capable of working under limited supervision, able to evaluate operating conditions and exercise sound judgment and problem-solving skills. * Self-motivated, willing to learn beyond production activities. * Must be prepared to work overtime and inconvenience hours.