Project Manager – Audit

3 weeks ago


Bengaluru, India Sagility Full time
Job Title: Project Manager

Job Location: Bangalore (Work from Office).

Job Descriptio

- n: Develop and execute validation plans, protocols, reports, and risk-based validation strategies, ensuring Compliance with regulatory requiremen- ts.compliance-related tasks including system documentation, review, and approval of CSV deliverabl- es.with a cross-functional team to integrate validation activities into the product development lifecyc- le.in audits and inspections related to the project supported, including finding solutions to compliance gaps identifi- ed.in system releases as a validation S- ME.a programme to ensure compliance concerning the regulatory requirements e.g., 21CFR part 11, EU Annex 11, and GAM- P5.control, CAPA, Deviation, and Root causes analys- is.of Digitalization process for Laboratory applications & Enterprise applicatio- ns.process (Incident, Problem management, and change managemen

t).

Job Requi

- rementGraduate 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 & Comp- lianceGood understanding of Enterprise level Application audit and co- ntrolsWell-versed with ITAC, IPE & ITAC co- ntrolsUnderstand each control and perform an internal audit every qu- arter.Define a process for Audit artifacts collection and re

views.

Regards,

ealth.com

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