QA-CSV(Computer System Validation)

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 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