QA-CSV (Computer System Validation)

As a QA-CSV at GSC Technolabs, a Group of GSC Technologies Ltd., based in Ahmedabad, you will play a pivotal role in ensuring the compliance and validation of systems with applicable regulations such as FDA, EMA, and GAMP 5. With 3-5 years of experience and a Bachelor's degree, you will be responsible for various key job responsibilities. Your primary responsibilities will include validation planning where you will develop and maintain Validation Master Plans (VMP) and define validation strategies based on risk and regulatory impact. Documentation will be a crucial aspect of your role, involving creating and reviewing validation documentation like User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Validation Protocols (IQ, OQ, PQ), Traceability Matrix, and Final Validation Reports. In terms of testing and execution, you will lead or perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing, document test results and deviations, conduct software testing as per requirements, and oversee internal/external releases. Compliance will be a key focus area, where you will ensure that systems comply with relevant regulations, participate in audits and inspections, and maintain audit trails and data integrity practices. You will also be required to perform risk assessments and impact analyses for changes to validated systems, evaluate system changes, determine the need for revalidation, and support Change Control processes. Collaboration will be essential as you work with QA, IT, engineering, and business units to support the validation lifecycle, train users and system owners on compliance requirements, and manage validation activities throughout the system lifecycle from development to decommissioning. This is a full-time, permanent position with benefits including Provident Fund, day shifts (Monday to Friday, morning shift), performance bonus, and yearly bonus. The ability to commute/relocate to Ahmedabad, Gujarat, is required. The ideal candidate will have relevant skills mentioned in the job description, a Bachelor's degree, at least 3 years of experience in software testing, and 2 years of experience in Computer System Validation. Work location will be in person at Ahmedabad, Gujarat.,