Indotronix International Corporation
  • Atlanta, GA, United States
May 22, 2022  
Job Summary: Interprets and understands relevant GxP regulations and standards and provides coaching/guidance to ensure enforcement and consistent application of GxP requirements Executes, manages and documents the periodic reviews of global GXP IT systems Review and provide coaching/oversight for non-GxP changes (MOCs) Authors and/or reviews GxP technical documents (SOPs, Work Instructions, Risk Assessment, URS, CS, DS, IOQ, PQ/UAT, RTM, Reports, etc.) as assigned. Provide GxP project support for CSV systems (new implementations, upgrades, decommission, etc.) as assigned Provides quality review of relevant validation documentation pre and post execution for accuracy, completeness and to ensure compliance with regulatory and client requirements. Collaborate w/ department personnel (QA, IT, Operations, etc.) for assigned projects Maintains and periodically updates global CSV inventory, as required. Other duties may be assigned,...
Indotronix International Corporation Remote * (Hampton, VA, USA)
May 18, 2022  
Job Summary:  Interprets and understands relevant GxP regulations and standards and provides coaching/guidance to ensure enforcement and consistent application of GxP requirements  Executes, manages and documents the periodic reviews of global GXP IT systems  Review and provide coaching/oversight for non-GxP changes (MOCs)  Authors and/or reviews GxP technical documents (SOPs, Work Instructions, Risk Assessment, URS, CS, DS, IOQ, PQ/UAT, RTM, Reports, etc.) as assigned.  Provide GxP project support for CSV systems (new implementations, upgrades, decommission, etc.) as assigned  Provides quality review of relevant validation documentation pre and post execution for accuracy, completeness and to ensure compliance with regulatory and client requirements.  Collaborate w/ department personnel (QA, IT, Operations, etc.) for assigned projects  Maintains and periodically updates global CSV inventory, as required.  Other duties...
Indotronix International Corporation Hampton, NJ, United States