QA-csv(Computer System Validation)

2 weeks ago

Ahmedabad Gujarat, India GSC Technolabs Private Limited Full time

**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

Schedule:

- Day shift
- Monday to Friday
- Morning shift

Supplemental Pay:

- Performance bonus
- Yearly bonus

Ability to commute/relocate:

- Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Bachelor's (preferred)

**Experience**:

- Software testing: 3 years (required)
- Computer System Validation: 2 years (required)

**Location**:

- Ahmedabad, Gujarat (required)

Work Location: In person

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