qa-csv

5 days ago

Ahmedabad, Gujarat, India GSC Technolabs Full time ₹ 5,00,000 - ₹ 15,00,000 per year

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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