SENIOR QC LIMS TECHNICIAN (RE-ADVERTISEMENT) ( Hay Level 15/C4) Internal and External

KEY PERFORMANCE AREAS PRINCIPAL ACCOUNTABILITIES 1. 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. 2. 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. 3. 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 4. 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. 5. 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. 6. 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).