IT Qualification & Validation Support/Engineer

Job Description

Job Purpose:

• Housekeep, troubleshoots, and maintains GxP computerized systems at EGCA site (e.g., desktop, lab systems, laptops, remote printers, LAN, business applications, etc.) to support company’s finished goods labs, warehouse, dispensing and productions unit.
• Perform full validation and qualification package for GxP computerized systems (URS, QP, IQ, OQ, PQ, UAT VR, etc) using One-CSV documents for all coming projects and re-evaluation.
• Adaptable with a focus on Discipline of Execution to ensure quality of deliverables, adherence to standards, and continuous improvement for Data Integrity process.
• Use data integrity framework to identify erroneous data points. Troubleshoot and resolve quality issues with sourced, processed and/or consolidated data, irrespective of cause.
• Information security and IT quality coordination for IT-TechOps.

Major Accountabilities:

• Support implementation and monitoring of the Information Governance Framework within IT function to ensure the integrity, confidentiality and availability of information owned, controlled or processed by the Novartis Organization
• Conduct Quality Reviews to evaluate if processes and deliverables fulfill the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement.
• Responsible for ensuring quality and compliance to information governance within projects and operations of IT function / business organization
• Works with project teams to assess potential risks, advice on risk mitigation and to solve compliance issues.
• Issuing initial system risk assessment and draft user requirement.
• Identify System requirement. Requirements come from varies sources including: the business process, Health Authority regulations, national policies, legislations, Quality Modules, Standards, and operating procedures.
• Issuing Quality Risk assessment to determine risk categorization of the system.
• Issuing Supplier assessment focusses on Supplier quality management system. Processes related to the service/product they will be suppling. Ability to meet service level agreements including adequate expertise and resources.
• Issuing Validation plan to determine the validation approach. (Test Strategies, Functional specification, Design Specification, Installation procedures, Configuration specification)
• Issuing Validation report.
• Updating Site Validation Master Plan with new systems.
• Implement User and Security Management with respect to ISEC and Records Management procedures.
• Incident and problem management. (Handling Deviations starting from investigations until CAPA).
• Responsible for Disaster recovery plan. (Business continuity, backup and restore)
• Follow up Contracts and agreements of suppliers and Stakeholders.
• Issuing Validation periodic review reports.
• Provides technical support and guidance to client through consulting, teaching and publication of documentation.
• Analyze equipment problems and take corrective action.
• Participate in the evaluation of new software packages and equipment
• Applies appropriate testing procedures and scripts
• To ensure compliance to all the site applicable HSE policies and procedures to ensure safe work environment and zero harm to people.