3 - 5 years

4 - 7 Lacs

Posted:None| Platform: Naukri logo

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Full Time

Job Description

Job Location: Ahmedabad

Experience Year : 3-5 Years

Qualification: Bachelors

Position: QA-CSV

Job Type: WFO

Company Name: GSC Technolabs. A Group of GSC Technologies Ltd.

Key Job Responsibilities for a QA-CSV Role:

Validation Planning:

    • Develop and maintain Validation Master Plans (VMP).
    • Define a validation strategy based on risk and regulatory impact

Documentation:

    • Create and review validation documentation, including:
    • User Requirements Specifications (URS)
    • Functional Specifications (FS)
    • Design Specifications (DS)
    • Validation Protocols (IQ, OQ, PQ)
    • Traceability Matrix
    • Final Validation Reports

Testing & Execution:

    • Lead or perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing.
    • Document test results and deviations.
    • Software Testing as per requirements
    • Internal/ external release.

Compliance:

    • Ensure systems comply with applicable regulations (FDA, EMA, GAMP 5).
    • Participate in audits and inspections.
    • Maintain audit trail and data integrity practices.

Risk Assessment:

    • Perform risk assessments and impact analyses for changes to validated systems.

Change Management:

    • Evaluate system changes and determine need for revalidation.
    • Support Change Control processes.

Collaboration:

    • Work with QA, IT, engineering, and business units to support the validation lifecycle.
    • Train users and system owners on compliance requirements.

System Lifecycle Support:

    • Manage validation activities through system development, implementation, maintenance, and decommissioning.

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