Aditya Kumar Singh Email & Phone Number

Manesar, Haryana, India

Lead Validation activity for the Global computerized systems• Project Management and end-to-end delivery of CAT 3,4 & 5 systems to improve compliance in terms of validation• Providing strategies for process Validation, SOP authoring, review, and approvals.• Lead the Change Management GxP Approval for Enterprise Computerized systems,Infrastructure & network changes • Define the Change Management Process for GxP approvals • Validation Project Management for small to large projects.• Author major validation documents like site master System Classification Assessment(SCA), validation Plan, Risk Assessment, Validation Report & RTM.• Perform validation review of documentation to support the validation of the system (Like SRS, RA, Design document, IQP, OQP & PQP etc).• Promoting a culture of quality excellence, process improvement, and Computer Software Assurance (CSA) implementation for validation projects.• Develop relationships with stakeholders, and sites to ensure a collaborative work environment.• Provide mentorship to new team members to enable them in meeting their accountabilities.• Ensuring training compliance for the IT & Business & GxP Approvers• Responsible for reviewing and revising the global SOPs, work instructions & CSV Deliverables templates to meet the compliance and business objectives

Manesar

• Lead Validation activity for the Global computerized systems• Project Management and end-to-end delivery of CAT 3,4 & 5 systems to improve compliance in terms of validation• Providing strategies for process Validation, SOP authoring, review, and approvals.• Lead the Change Management GxP Approval for Enterprise Computerized systems,Infrastructure & network changes • Define the Change Management Process for GxP approvals • Validation Project Management for small to large projects.• Author major validation documents like site master System Classification Assessment(SCA), validation Plan, Risk Assessment, Validation Report & RTM.• Perform validation review of documentation to support the validation of the system (Like SRS, RA, Design document, IQP, OQP & PQP etc).• Promoting a culture of quality excellence, process improvement, and Computer Software Assurance (CSA) implementation for validation projects.• Develop relationships with stakeholders, and sites to ensure a collaborative work environment.• Provide mentorship to new team members to enable them in meeting their accountabilities.• Ensuring training compliance for the IT & Business & GxP Approvers• Responsible for reviewing and revising the global SOPs, work instructions & CSV Deliverables templates to meet the compliance and business objectives.

Gurgaon, India

• Lead Validation activity for the Global IT Infrastructure, Corporate IT, R&D at Sun Pharmaceutical Industries Ltd. Gurgaon• Project Management and end-to-end delivery of CAT 5 system to improve compliance in terms of paperless validation, inventory, and user access management.• Providing strategies for process automation and Validation, SOP authoring, review, and approvals.• Validation Project Management for small to large projects.• Author major validation documents like site master validation Plan, Validation Report & RTM.• Perform validation review of documentation to support the validation of site equipment and system (Like URS, FRS, FRA, CS, DS, Test Plan, Test Script, etc).• Promoting a culture of quality excellence, process improvement, and Computer Software Assurance (CSA) implementation for validation projects.• Develop relationships with stakeholders, and sites to ensure a collaborative work environment.• Provide mentorship to new team members to enable them in meeting their accountabilities.• Ensuring training compliance for the IT department and responsible for reviewing and revising the global SOPs to meet the compliance and business objectives.• Handling audits for IT systems • Reviewing Server Qualification

Gurgaon, India

•Handling Validation activity for the Global IT Infrastructure, Corporate IT, R&D at Sun Pharmaceutical Industries Ltd. Gurgaon(erstwhile Ranbaxy Laboratories Ltd)• End-to-end delivery of CAT 5 system to improve compliance in terms of Computer System validation and user access management.• Providing strategies for process automation and Validation, SOP authoring, review, and approvals.• Handling Validation for small to large projects.• Author major validation documents like site master validation Plan, Validation Report & RTM.• Perform validation review of documentation to support the validation of site equipment and system (Like URS, FRS, FRA, CS, DS, Test Plan, Test Script, etc).• Promoting a culture of quality excellence, process improvement, and Computer Software Assurance (CSA) implementation for validation projects.• Develop relationships with stakeholders, and sites to ensure a collaborative work environment.• Ensuring training compliance for the IT department • Reviewing Server Qualification

New Delhi Area, India

Software Design and Testing of internal Software ie. Composing message to display on “LED Display Board v2.0” according to user’s desire, by writing a slogan message that is to be displayed on line 1 and select no of parameters to display on the particular station then station name, and select date, parameters and units that is to be displayed on line2 on display board and transferring viaGSM network using serial communication.

Bachelor Of Technology (B.Tech.), Computer Science, A

10+2, Intermediate(Ssc), 71.40%

10Th, High School(Hsc), 74.10%

Got distinction in 4 subjects out of 6