Job Description

Key Performance Areas
PRINCIPAL ACCOUNTABILITIES
System Support And Maintenance

• Provide day-to-day technical support for the Laboratory Information Management System (LIMS).
• Perform system updates, configurations, and routine maintenance to ensure optimal performance.
• Keep abreast with technology.
• Troubleshoot and resolve technical issues related to LIMS functionality.

User Support And Training

• Assist laboratory staff in navigating and using the LIMS effectively.
• Conduct user training sessions and create user guides or documentation as needed.
• 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).

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

• 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 for maintenance of LIMS system.
• Coordinate and initiate risk/ impact assessments and plans to address LIMS deficiencies.
• Manage implementation of change controls and processes related to LIMS.

KNOWLEDGE AND SKILLS:
Skills and Competencies
Familiarity with LIMS platforms and their application in laboratory workflows.
Proficiency in database management and data analysis tools. (Preferably SQL Server)
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., SQL, Crystal syntax and Basic syntax).
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

QUALIFICATIONS AND EXPERIENCE

• National Diploma /Bachelors degree in Chemistry or Microbiology, Information Systems, or a related field
• Minimum of 5 years technical experience working with Laboratory Information Management Systems as a LIMS Administrator with certification for:

- LIMS Administration or equivalent
- LIMS Basic Programming or equivalent
- SQL certification or equivalent
- Crystal reports certification or equivalent

• Minimum of 3 years of experience in laboratory operations
• Knowledgeable on cGMP/PICs regulations/guidelines related to laboratory software
• 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.