Project Manager – Audit

3 weeks ago


Bangalore City, India Sagility Full time

Job Title: Project Manager Job Location: Bangalore (Work from Office). Job Description: Develop and execute validation plans, protocols, reports, and risk-based validation strategies, ensuring Compliance with regulatory requirements.Compliance-related tasks including system documentation, review, and approval of CSV deliverables.With a cross-functional team to integrate validation activities into the product development lifecycle.In audits and inspections related to the project supported, including finding solutions to compliance gaps identified.In system releases as a validation SME.A programme to ensure compliance concerning the regulatory requirements e.G., 21CFR part 11, EU Annex 11, and GAMP5.Control, CAPA, Deviation, and Root causes analysis.Of Digitalization process for Laboratory applications & Enterprise applications.Process (Incident, Problem management, and change management).Job RequirementGraduate for Technical education BE/B Tech, MCA, M Tech.Overall, 10 years of experience in Process and Audit ( ISO or Enterprise Audit)Min 3 years of experience as part of Statutory audit & ComplianceGoodunderstanding of Enterprise level Application audit and controlsWell-versed with ITAC, IPE & ITAC controlsUnderstand each control and perform an internal audit every quarter.Define a process for Audit artifacts collection and reviews.Regards,



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