Sr.Officer - Infotech

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Job Description

A) Operations, control and Monitoring and cGMP: Compliance: - 1. Ensure compliance with all cGMP, GxP, or any other regulatory requirements, including EH&S requirements. 2. Ensuring compliance and Implementation of all SOPs including Corporate, Site Specific. 3. Ensure Computer System Software Validation and Maintain the Validated status of all Computerized System Software as per SOPs in line with cGMP guidelines. 4. Identifying GAPs in current practice and plan mitigation for each GAP as per the agreed timeline. 5. Prepare a comprehensive support matrix to support day-to-day functions. 6. Maintain control to ensure that all team members are trained on the relevant SOPs and support continuous learning/ capability building. 7. Encourage a culture of quality compliance and open communication that supports all employees to raise quality concerns or suggest improvements. 8. User ID creation as site IT administrator 9. Preparation and Review of Incident Investigation report, Scheduler, Preventive Maintenance, Implementation of Security Controls. 10. Periodical Audit Trail Review as per SOP and participating in various internal/External audits. Reports and Management Review 1. Prepare and participate in management review to provide status on various ongoing projects progress, compliance status and related actionable.2. Carry out a periodical audit to access the IT system and give effective solutions if any discrepancy is found. Also, handle escalations and downtime and ensure the change control process. Budget and Spend Management 1. Support in preparation, and utilization of financial budget and effective usage through periodic review of spent and upcoming priorities. 2. Work on avenues of Cost optimization without losing critical business requirements. People Management 1. Manage IT engineers and Support vendors hence responsible for managing operations/Manufacturing systems/QC systems. 2. Monitor and raise Short-term and Long-term planning for Location IT Manpower 3. To provide support to project team members for New IT Infra rollout, and network support in implementation. Operations: - 1. Manage and ensure information technology computer systems at the Site by planning, developing, organizing, controlling, and evaluating IT policies, standards, procedures, and electronic data operations. 2. Ensure required security controls and safe IT working to be established in the environment. 3. Ensure and facilitate the Backup, Restore, and archive of all electronic data. 4. User Management of computerized systems in accordance with the applicable SOPs. 5. Vendor Coordination, Asset Management. Review the IT asset data, and ensure physical assets and their system records. Project Management: 1. Handle Local Plant Changes. 2. Lead Corporate initial. B) QAMS and other Software systems: 1. User Management of all Server and Standalone Systems of Quality, PD Lab, AD Lab, R&D, Warehouse and all Manufacturing plant i.e. IT Administration for any business-related software/application installed in the environment. 2. Data Backup, Restoration and Archival. 3. Preparation and Review of data log (Backup, Archival, Restoration, etc.) as per the applicable SOPs. 4. All Scheduler preparation and review activity as per the SOPs. 5. Verification and review of data security controls and preventive Maintenance of instrument-connected PCs