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INDUS Systems seeks a qualified IT professional to manage GxP-related IT activities at the Patalganga site. You will implement cGMP SOPs, maintain IT servers, and ensure compliance with audit observations while coordinating with the corporate IT team for remote software and web applications.
The role includes training engineers on cGMP IT principles and ensuring documentation per regulatory requirements.
As processes are becoming more complex, competitive and demanding, businesses are constantly exploring new ways to deploy effective solutions. We at INDUS Systems, over the years, have synchronised our team to offer best-of-breed solutions from leading technology partners coupled with our Professional Services to help customers protect their IT investments, reduce costs and grow their businesses. Our IT Solutions increase people efficiency, reduces infrastructure footprint which acts as a catalyst towards quantum business growth. We thrive to be a hand-holding partner in customer's journey.
Overall responsibility for all GxP-related IT activities at the Patalganga location.
Implementation of standard operating procedures as per current Good Manufacturing Practice (cGMP) guidelines issued by Quality Assurance.
Maintain Chromeleon and non-Chromeleon application servers as per infrastructure policies.
Ensure implementation of and adherence to applicable SOPs.
Maintain IT documentation as per cGMP requirements.
Ensure compliance with audit observations.
Implement and review desktop policies on all respective GxP systems.
Provide technical support to vendors during new installations or IT infrastructure troubleshooting.
Evaluate user requirements and ensure adequate capacity to meet requirements on time.
Prepare, review, and execute qualification and validation documents related to Information Technology.
Impart training to engineers on cGMP and IT principles.
Coordinate with the corporate IT team for remote software and web applications.
Provide laboratory IT support and resolve IT-related issues.
Review SCOM alert mechanisms for IT infrastructure.
Coordinate with team members to troubleshoot IT-related problems.
Handle any other responsibilities or assignments allocated by the Department Head.
Provide technical support to the Unit II team.
Review OT and DCS vCenter on a daily basis.
Review the EBR application and provide support to the production team.
Provide support for OT firewall rule creation.
Provide OT network support.
Perform workstation, server, and tablet PC qualification.
Handle terminal creation, weighing balance configuration, and printer configuration in the PAS-X application.
Provide Hyper-V infrastructure support for the Wi-Fi controller in Unit II.
Configure Android tablets for the SAP PPM application.
Create and configure servers in vCenter and Hyper-V.
Handle the Fortinet Secure Remote Access Proof of Concept (POC) project.