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    Job · 20642160

    PUNE · FULLTIME

    CSV Engineer

    R Systems International

    R Systems International

    Pune · onsite · Posted 12d ago

    Sourced fromNaukri
    Undisclosed5–10 yrsfulltimePune

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    Section · 01

    About this role

    Roles and Responsibilities :

    • Design, develop, test, and maintain CSV (Computer System Validation) protocols for pharmaceutical equipment and systems.
    • Collaborate with cross-functional teams to ensure compliance with GAMP (Good Automated Manufacturing Practice) guidelines.
    • Conduct deviation investigations and implement corrective actions to maintain data integrity.
    • Develop IQ/OQ/PQ documents for new equipment installations or modifications.

    Job Requirements :

    • 5-10 years of experience in CSV engineering in the pharmaceutical industry.
    • Strong understanding of computer system validation principles and regulations (e.g., FDA 21 CFR Part 11).
    • Experience with GXP (Good X Practices) development and implementation.
    • Proficiency in creating IQ/OQ/PQ documents using standard templates.

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    Section · 02

    Skills

    data integrityGampLoss ForecastingPQIQdeviation21 Cfr Part 11Computer System ValidationCSVGxPOQ

    Section · Company

    About R Systems International

    R Systems International

    R Systems International

    IT Services & Consulting

    3.7k+

    employees

    1993

    33 years old

    El Dorado Hills, California

    United States (USA)

    About

    R Systems is a leading digital product engineering company that designs and develops chip-to-cloud software products, platforms, and digital experiences.

    Industries

    IT Services & ConsultingAnalytics & KPO

    Employee ratings

    1,332 reviews

    3.6/ 5

    Culture

    3.4

    Career growth

    3.1

    Work-life

    3.7

    Employees rate it well for

    Job Security167Work Life Balance145Senior Management132Salary121Work Culture91

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