Project Manager – Audit

3 weeks ago


bangalore, 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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