1) Responsible for Implementation of System Policies for Windows Domain Server and Application, Folder & Database Management of GxP Computerized System.2)Responsible for Quality Oversight of GxP Software and designing of Validation strategy for all Validation activities as per Waterfall, Type V and Agile Model. 3) Responsible for preparation & review/ execution of CSV/CSA documents like User Requirement Specification, GxP Assessment Checklist, Project Validation Plan, Quality Risk Management (QRM), Functional Requirement Specification (FRS), Configuration Specification (CS), Qualification scripts (IQ, OQ, PQ), Test protocols and reports, Requirement Traceability Matrix (RTM), Validation Summary Report (VSR) and System Release Certificate (SRC) for Application, Enterprise, LMS and Cloud based Software. 4)Responsible for periodic review & gap assessment for critical GxP Computerized System to ensure compliance of regulatory requirements.5) Responsible for Quality Oversight of Excel Spreadsheet Validation.6) Responsible for selection of vendor for procurement/ development of new Software’s e-Compliance and monitoring for Application, Enterprise, LMS and Cloud based System.7) Responsible for Preparation/ Review of SOPs for Quality Management System (QMS) related to Training of Employees, Change Control, Deviation, CAPA, Quality Risk Management etc., I.T SOPs like Password Management, Data Back Up, Restore and Archival, Privilege Management etc. and responsible to impart training on SOPs to employees across cross functional department.8) Responsible for review of Change Control, Deviation, CAPA & its Effectiveness Monitoring.9)Preparation and Review of System Retirement & Decommissioning and Business Continuity Plan.10) Exposure in Application, Enterprise and LMS Software like LIMS, Trackwise, SAP, Empower, Chromeleon, mySugr GmbH, Nichelon 5 CMS Training Management, Veeva Vault, Test Management Tool like Qase, Atlassian Software and Azure DevOps.

1) Responsible for preparation & review/ execution of CSV documents like User Requirement Specification, GxP Assessment Checklist, Project Validation Plan, Quality Risk Management (QRM), Functional Requirement Specification (FRS), Configuration Specification (CS), Qualification scripts (IQ, OQ, PQ), Test protocols and reports, Requirement Traceability Matrix (RTM), Validation Summary Report (VSR) and System Release Certificate (SRC) for Enterprise Software.2) Responsible for Preparation/ Review of SOPs for Quality Management System (QMS) related to Training of Employees, Change Control, Deviation, CAPA, Quality Risk Management etc., I.T SOPs like Password Management, Data Back Up, Restore and Archival, Privilege Management etc. and responsible to impart training on SOPs to employees across cross functional department.3) Exposure in Enterprise Software like LIMS, SAP, Testing Management Tool like Qase and Atlassian Software.

1) Responsible for Quality Oversight of GxP Software & designing of Validation strategy for all Validation Activities as per Type V and Agile Model.2) Responsible for preparation & review of CSV documents like User Requirement Specification, GxP Assessment Checklist, Project Validation Plan, Quality Risk Management (QRM), Functional Requirement Specification (FRS), Qualification scripts (IQ, OQ, PQ), Test protocols and reports, Requirement Traceability Matrix (RTM), Validation Summary Report (VSR) and System Release Certificate (SRC) for Application and Enterprise Software.3) Exposure in Application and Enterprise Software like LIMS, Empower, Chromeleon, mySugr GmbH, Testing Management Tool like Qase, Atlassian Software and Azure DevOps

1) Responsible for Implementation of System Policies for Windows Domain Server and Application, Folder and Database Management of GxP Computerized System.2) Responsible for Quality Oversight of GxP Software and designing of Validation strategy for all Validation activities as per Waterfall, Type V and Agile Model.3)Responsible for preparation & review/ execution of CSV documents like User Requirement Specification, GxP Assessment Checklist, Project Validation Plan, Quality Risk Management (QRM), Functional Requirement Specification (FRS), Configuration Specification (CS), Qualification scripts (IQ, OQ, PQ), Test protocols and reports, Requirement Traceability Matrix (RTM), Validation Summary Report (VSR) and System Release Certificate (SRC) for Application, Enterprise, SCADA, LMS and Cloud based Software.4) Responsible for periodic review & gap assessment for critical GxP Computerized System to ensure compliance of regulatory requirements.5) Responsible for selection of vendor for procurement/ development of new Software’s e-Compliance and monitoring and Vendor Audit Management for Application, Enterprise, SCADA, LMS and Cloud based System.6) Responsible for Preparation/ Review of SOPs for Quality Management System (QMS) related to Training of Employees, Change Control, Deviation, CAPA, Quality Risk Management etc., I.T SOPs like Password Management, Data Back Up, Restore and Archival, Privilege Management etc. and responsible to impart training on SOPs to employees across cross functional department.7)Responsible for review of Change Control, Deviation, CAPA & its Effectiveness Monitoring.8)Preparation and Review of System Retirement & Decommissioning and Business Continuity Plan9)Exposure in Application, Enterprise, SCADA and LMS Software like LIMS, Caliber QAMS, SAP, ICDAS, SDMS, Empower, Chromeleon, Nichelon 5 CMS Training Management, Veeva Vault, Test Management Tool like Qase, Atlassian Software and Azure DevOps.

1) Responsible for Implementation of System Policies for Windows Domain Server and Application, Folder and Database Management of GxP Computerized Software System.2) Responsible for Quality Oversight of GxP Software Quality & Validation and Supporting Validation strategy for all Validation Activities as per Type V and Agile Model.3) Responsible for preparation & review/ execution of CSV documents like User Requirement Specification, GxP Assessment Checklist, Project Validation Plan, QRM, Functional Requirement Specification (FRS), Configuration Specification (CS), Qualification scripts (IQ, OQ, PQ), Test protocols and reports, RTM and Validation Summary Report for Application, Enterprise SCADA and LMS Software.4) Responsible for Review of periodic audit trail for chromatographic and non- chromatographic systems.5) Responsible for Quality Oversight of Excel Spreadsheet Validation.6) Responsible for periodic review & gap assessment for critical GxP Computerized System to ensure compliance of regulatory requirements.7) Responsible for selection of vendor for procurement/ development of new Software’s e-Compliance and monitoring and Vendor Audit Management for Application, Enterprise, SCADA and LMS System. 8) Responsible for Preparation/ Review of SOPs for Quality Management System (QMS) related to Training of Employees, Change Control, Deviation, CAPA, Quality Risk Management etc., I.T SOPs like Password Management, Data Back Up, Restore and Archival, Privilege Management etc. and responsible to impart training on SOPs to employees across cross functional department.9) Responsible for review of Change Control, Deviation, CAPA & its Effectiveness Monitoring.10) Preparation and Review of System Retirement & Decommissioning Plan.11) Exposure in Application, Enterprise, SCADA and LMS Software like LIMS, Trackwise, SAP, ICDAS, Empower, Chromeleon, Nichelon 5 CMS Training Management, Testing Management Tool like Qase, Atlassian Software and Azure DevOps

1) Responsible for Implementation of System Policies for Windows Domain Server and Application, Folder and Database Management of GxP Computerized Software System.2) Responsible for preparation & review/ execution of CSV documents like User Requirement Specification, GxP Assessment Checklist, Project Validation Plan, Quality Risk Management (QRM), Functional Requirement Specification (FRS), Configuration Specification (CS), Qualification scripts (IQ, OQ, PQ), Test protocols and reports, Requirement Traceability Matrix (RTM) and Validation Summary Report for Application, Enterprise, SCADA and LMS Software as per V-Model.3) Responsible for Review of periodic audit trail for chromatographic and non- chromatographic systems.4) Responsible for Quality Oversight of Excel Spreadsheet Validation.5) Responsible for periodic review & gap assessment for critical GxP Computerized System to ensure compliance of regulatory requirements.6) Responsible for selection of vendor for procurement/ development of new Software’s e-Compliance and monitoring and Vendor Audit Management for Application, Enterprise, SCADA and LMS System.7) Responsible for Preparation/ Review of SOPs for Quality Management System (QMS) related to Training of Employees, Change Control, Deviation, CAPA, Quality Risk Management etc., I.T SOPs like Password Management, Data Back Up, Restore and Archival, Privilege Management etc. and responsible to impart training on SOPs to employees across cross functional department.8) Responsible for review of Change Control, Deviation, CAPA & its Effectiveness Monitoring.9) Exposure in Application, Enterprise, SCADA and LMS Software like LIMS, Caliber QAMS, SAP, ICDAS, Empower, Chromeleon, Nichelon 5 CMS Training Management, Testing Management Tool like Qase, Atlassian Software and Azure DevOps.

1) Analysis of raw materials.2) In hand experience in Analytical Method Development activities.

1) Analysis of raw materials, finished products and stability samples.2) In hand experience in calibration of analytical instruments.3) In hand experience in Analytical Method Development, Method Validation, Method Verification and Method Transfer & cleaning validation activities.