Technical Lead

9 hours ago

tamil nadu, India CitiusTech Full time

Role Overview:We are seeking a seasoned Verification and Validation Lead to spearhead the Computer Systems Validation (CSV) activities for a cutting-edge Ophthalmology digital product developed for CitiusTech. This role demands deep expertise in regulated environments, particularly in GxP-compliant systems, and a strong grasp of FDA 21 CFR Part 11 standards. The ideal candidate will lead validation planning, execution, and documentation, ensuring alignment with CitiusTech compliance framework and quality expectations.Key Responsibilities:Lead the conception, planning, and execution of CSV activities in a regulated healthcare environment.Define validation scope, objectives, and timelines in alignment with CitiusTech SOPs and compliance requirements.Collaborate with Project Managers and cross-functional stakeholders to integrate validation into overall project planning.Create, update, and review QA deliverables including:Test PlansEffort EstimationsTraceability MatrixValidation Summary ReportsEnsure documentation complies with GxP, 21 CFR Part 11, and internal SOPs.Oversee qualification/validation activities for new and existing systems.Ensure proper execution of test protocols, defect logging, and resolution tracking.Monitor test coverage, execution progress, and quality metrics.Identify and address gaps in validation deliverables such as:Functional/Design SpecificationsTest ProtocolsSOPsRecommend corrective actions and mitigation strategies.Support sprint planning by setting validation goals and identifying testable backlog items.Coordinate test management activities including test case design, execution, and defect triage.Facilitate issue resolution and ensure timely closure of validation tasks.Liaise with CitiusTech QA, business, and technical teams to ensure alignment and approvals.Participate in formal reviews and audits of validation artifacts.Provide validation status updates and insights during governance meetings.Ensure validation activities meet regulatory and audit requirements.Maintain traceability and readiness for internal/external audits.Drive continuous improvement in validation processes and documentation quality.Mandatory Technical Skills:Proven experience in Computer Systems Validation (CSV) in regulated environments.Strong understanding of GxP, 21 CFR Part 11, and FDA compliance.Hands-on experience with Test Management Tools (e.g., HP ALM, Jira, Zephyr).Expertise in Traceability Matrix, Test Protocols, and Validation Summary Reports.Familiarity with Agile/Scrum methodologies and sprint-based validation planning.Experience in defect lifecycle management and quality metrics tracking.Excellent documentation skills aligned with regulated industry standards.Desired Technical Skills:Experience with Ophthalmology or Life Sciences digital products.Knowledge of Risk-Based Validation approaches.Exposure to Cloud-based platforms and SaaS validation.Familiarity with automated testing frameworks (e.g., Selenium, TestNG).Understanding of data integrity principles and audit trail requirements.Experience with electronic records and electronic signatures (ERES) compliance.Working knowledge of DevOps pipelines and CI/CD validation.Soft Skills & Attributes:Strong leadership and stakeholder management capabilities.Excellent communication and presentation skills.Detail-oriented with a proactive approach to problem-solving.Ability to work independently and collaboratively in cross-functional teams.

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