Senior QC LIMS Technician ( Hay Level 15/C4)

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:

• 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

• National Diploma in programming or equivalent.
• 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.