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Staff IT Security, Risk & Compliance Analyst

7 - 8 years

11 - 14 Lacs

Bengaluru

Posted:3 months ago| Platform: Naukri logo

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Skills Required

GIS Change management SAP LMS Life sciences Customer service DBMS Virtualization Auditing Salesforce

Work Mode

Work from Office

Job Type

Full Time

Job Description

Advises project teams and internal GIS customers on validation scope, risk, and validation approach. Operate independently to manage end to end compliance activities within projects. Develops and maintains software and hardware testing protocols (knowledge of different types of testing such as integration, unit, regression testing). Responsible for Validation Documentation. Participates in project and system requirements gathering/authoring, coordinates activities with business users and analysts. Coordinates the Change Management process within the GIS organization. Reviews system changes to provide compliance assessments and closure summaries that are audit ready. Investigates root-cause of defects, failures, and authors and/or investigates Non-conformances and CAPAs. Requirements: 7+ years of experience working in Life sciences industry focusing on Computer Systems Validation. Strong oral and written skills to persuade, direct and advise stakeholders on regulatory compliance processes. Strong organizational skills to maintain and manage multiple validation projects. Experience with enterprise applications such as SAP, LMS, Salesforce and EtQ, etc. Experience with Test Management Tools such as HP Quality Center, ValGenesis and TFS. Ability to articulate risk-based validation strategy and provide validation approach to meet the business needs. Excellent customer service and communication skills. Experience with regulations and frameworks - e.g., 21 CFR Part 820/11, ISO 13485, and GAMP. Experience with software development lifecycle activities, methodologies, testing and validation. Experience managing workload using IT Service Management ticketing tools, ServiceNow preferred. Experience with common IT infrastructure and applications, e.g., virtualization, directory services, storage, DBMS. People Leadership: Ensure Policies and Procedures are followed by direct reports Work with onshore leads for new and/or altering work assignments Experience/Education: Typically requires a minimum of 7 years of related experience with a bachelor s degree; or 5 years and a Master s degree

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Illumina
Illumina
www.illumina.com

Biotechnology Research

San Diego CA

5001-10000 Employees

95 Jobs

    Key People

  • Francis deSouza

    CEO

  • Michelle Carnahan

    SVP, Global Commercial Operations

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