Ing. Shruti Prafulla Anikhindi

is staying at home. 🏡

Bis 2019, Consultant - Quality and Compliance, Novo Nordisk Global Service Centre, Bangalore , India
Graz, Österreich

Fähigkeiten und Kenntnisse

Computer System Validation
GxP
GAMP-5
21 CFR Part 11
Quality Management
Quality assurance
SDLC
CSV
IT Periodic System
Technical Documentation
Annual Compliance Reports
Reporting
Business Development
Software-Qualitätssicherung

Werdegang

Berufserfahrung von Shruti Prafulla Anikhindi

  • 3 Jahre und 1 Monat, Mai 2016 - Mai 2019

    Consultant - Quality and Compliance

    Novo Nordisk Global Service Centre, Bangalore , India

    • Perform review of the configuration management of the systems against its baseline; documentation of the configuration review report • Review of the incidents, problems, change request, non-conformities and deviations to evaluate the overall validated status of the system(mainly for GxP IT systems) and there by assess their compliance according to the GAMP 5 guidelines • Providing solutions to the stakeholders from compliance perspective and thereby providing the value add to the stakeholder

  • 2 Jahre und 7 Monate, Feb. 2012 - Aug. 2014

    Associate Consultant- Quality Assurance and Compliance

    Wipro Technologies, Bangalore, India

    • Review and approve key deliverables as defined within the Master Validation Plan [MVP] in order to assess their compliance with applicable Pharmaceutical Regulatory bodies such as CFR 21 Part 11 and GSK QMS. • Review of Master Configuration Item List [MCIL] and performing Configuration management audits for GxP Applications • Conduct Internal Audits for SDLC Phases and for Regulatory Compliance adherence per customer QMS.

Ausbildung von Shruti Prafulla Anikhindi

  • 2007 - 2011

    Computer Science

    Visvesvaraya Technological University

Sprachen

  • Englisch

    Fließend

  • Deutsch

    Gut

XING – Das Jobs-Netzwerk

  • Über eine Million Jobs

    Entdecke mit XING genau den Job, der wirklich zu Dir passt.

  • Persönliche Job-Angebote

    Lass Dich finden von Arbeitgebern und über 20.000 Recruiter·innen.

  • 22 Mio. Mitglieder

    Knüpf neue Kontakte und erhalte Impulse für ein besseres Job-Leben.

  • Kostenlos profitieren

    Schon als Basis-Mitglied kannst Du Deine Job-Suche deutlich optimieren.

21 Mio. XING Mitglieder, von A bis Z