Role title: IT Application Support Engineer Key Responsibilities 1. Application Support & Maintenance o Monitor and maintain pharmaceutical applications to ensure optimal performance and availability. o Perform regular system health checks and proactive maintenance. o Apply patches, updates, and upgrades to applications as needed. 2. Hardware and Software Maintenance: o Install, configure, and maintain computer systems, printers, and other peripherals. 3. Help Desk Support: o Respond to user inquiries and provide technical support via phone, email, or inperson. o Troubleshoot application errors and work with development teams to implement fixes. o Diagnose and resolve hardware, software, and network issues promptly. o Provide timely and clear communication to end-users regarding the status of their requests. o Log and track support requests using a ticketing system. o Document incidents, problems, and resolutions for future reference. 4. System Administration: o Administer and maintain enterprise-level systems and applications. o Implement and manage Active Directory, user accounts, and group policies. o Perform regular system backups and ensure disaster recovery procedures are in place. o Support with provision and review where applicable of Audit Trails for system owners to review. 5. User Assistance & Training o Provide technical support and training to end-users on application functionalities and best practices. o Develop user guides, training materials, and documentation to assist users. 6. Collaboration & Communication o Work closely with cross-functional teams including IT, development, QA, and vendors to resolve application issues. o Communicate effectively with stakeholders to keep them informed of issue status and resolutions. 7. Compliance & Security o Ensure applications comply with regulatory requirements and industry standards (e.g., FDA, GMP, SOX). o Implement and maintain security protocols to protect sensitive data. 8. Performance Optimization o Analyze application performance and implement improvements to enhance efficiency and user experience. o Conduct regular reviews and assessments to identify areas for optimization. 9. Project Involvement o Participate in application-related projects, including new implementations, upgrades, and migrations. o Assist in requirement gathering, testing, and deployment phases. 10. Electronic System Implementation: o Project Manage the delivery of electronic systems, inc requirements gathering, scheduling, budgeting. o Develop and execute validation protocols (IQ, OQ, PQ) for GxP systems to ensure compliance with regulatory requirements. 11. Reporting & Documentation o Generate and analyze reports on application performance and usage. o Maintain detailed and accurate documentation of support activities, configurations, and processes. 12. Audit Support: a) Prepare for and participate in regulatory inspections and audits. b) Address findings and implement corrective and preventive actions (CAPAs) as needed. Qualifications • Education: Bachelor’s degree in Computer Science, Information Technology, or related field. • Experience: o Minimum of 3-5 years of experience in application support, preferably in the pharmaceutical or healthcare industry. o Experience with pharmaceutical applications such as LIMS, ERP, CRM, or specific pharma software. • Technical Skills: o Proficiency in SQL, database management, and scripting languages. o Familiarity with application servers, web servers, and middleware technologies. o Knowledge of pharmaceutical regulatory requirements and validation processes. • Soft Skills: o Strong problem-solving and analytical skills. o Excellent communication and interpersonal skills. o Ability to work independently and as part of a team. • Certifications (Preferred): ITIL, CompTIA A+, or other relevant certifications. • The IT Support Engineer should be adaptable, detail-oriented, and possess a customercentric approach to problem-solving. This role requires staying up to date with industry trends and technologies to provide effective support in a rapidly evolving IT landscape.
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