QA-CSV(Computer System Validation)

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 the 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.

Job Types: Full-time, Permanent

Pay: Up to ₹650,000.00 per year

Benefits:

• Provident Fund

Ability to commute/relocate:

• Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Are you an immediate Joiner.
• How frequent you can join?
• Do have relevant skill mentioned in JD ?

Education:

• Bachelor's (Preferred)

Experience:

• Computer System Validation: 2 years (Required)

Location:

• Ahmedabad, Gujarat (Required)

Work Location: In person