Devinder Kumar Email & Phone Number

With 19+ years of experience in GxP IT compliance, I am currently associated with the FRESENIUS Group as a Validation Expert. In this role, I oversee Qualification and Validation tasks for Cloud Migration and Infrastructure Qualification. Previously, I served as Assistant General Manager-QA IT in Corporate Quality Assurance at Fresenius Kabi Oncology Ltd., leading GxP IT operations for Fresenius Kabi (India Region). My responsibilities included ensuring that all computerized systems across Fresenius India region sites (Baddi, Gurgaon, and Kalyani) met regulatory compliance standards.I am adept at ensuring system compliance, managing enterprise applications, leading IT projects, validating computerized systems, and implementing IT policies and ensuring compliance as per information security management systems (ISMS). My experience extends to audit management, conducting IT training programs, and enhancing Data Integrity initiatives, including ALCOA+ attributes.Key Skills and Systems Proficiency:Enterprise Systems & Applications: Proficient in Serialisation, Empower, Trackwise, DMS, eBRM, LMS, QAMS, eLIMS, Distributor Management System (DMS), SharePoint, SQL, Dispensary Management System, ERP, Active Directory, and backup tools such as Acronis, Veeam, and HP Data Protector.Business Knowledge: Strong understanding of business applications in QC, manufacturing, packing, warehouse, and engineering.Regulatory Knowledge: Familiar with CFR Title 21 (parts 11, 210, and 211), GAMP5, electronic records/e-signature standards, and computer system validation.I have successfully led the IT department in numerous audits (USFDA, MHRA, Ukraine, Russia, Romania, ANVISA, TGA, ISO etc.) and served as a project lead, managing GxP and sales IT projects from implementation through post-go-live support. Additionally, I support senior management in leveraging IT solutions to streamline business processes effectively.

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  Doraha Institute Of Management And Technology, Doraha

  Mca