Team Lead - IT, QA & CSV

Roles & Responsibilities:
1. Computerized System Validation (CSV):
• Provide validation expertise for GxP-regulated applications, particularly in Drug Safety / Pharmacovigilance systems
• Review and approve key CSV deliverables including Requirements Specifications, Validation Plan, Test Plan, Traceability Matrix, Test Summary Report, Qualification Scripts (IQ/OQ/PQ), and Validation Summary Report
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, ICH and other global regulatory standards
• Support validation activities for SaaS-based implementations and cloud-hosted systems
• Collaborate with product owners and client stakeholders to gather and refine business, functional and non-functional requirements
• Author and review validation documentation aligned with risk-based validation approach and V-Model
• Lead system testing, functional testing, automation testing, IQ/OQ/PQ activities and UAT validation
• Ensure quality release of product features and validation artefacts
• Perform requirements analysis, risk assessment, profiling, and mitigation in collaboration with SMEs
• Manage defect tracking and resolution processes
• Provide expertise in Change Control, Deviation Management, CAPA, and Document Management systems
• Support internal and external audits for product and project documentation

2. Quality Assurance Operations:
• Ensure compliance with GxP requirements and QA best practices
• Maintain strong understanding of global regulatory guidelines (FDA, EMA, MHRA, PMDA)
• Ensure adherence to 21 CFR Part 11 and EU Annex 11 compliance requirements
• Anchor updates to Quality Management Systems (QMS)
• Participate in continuous improvement initiatives
• Coordinate revision, review, and approval of IT SOPs and GxP documentation
• Support client, internal, and regulatory audits

3. Team & Stakeholder Management:
• Lead and mentor validation and QA teams
• Manage stakeholder engagement and client communication
• Oversee direct reports, conduct performance evaluations, and support career development
• Drive onboarding, cross-training, and resource planning activities
• Collaborate with clients, project teams, and product owners to ensure smooth product releases and implementations
• Promote teamwork and maintain high-performance culture

Qualification:
• BE / B.Tech / MCA from a recognized institute
• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm)

Experience:
• Extensive experience handling regulatory, internal, and client audits
• 10+ years of experience in IT Quality Assurance and Computerized System Validation within Life Sciences
• Hands-on experience in validation activities (Manual and ALM-based)
• Strong exposure to Pharmacovigilance systems such as Argus or ARISg preferred
• Proven experience in risk-based validation and regulatory compliance frameworks

Skills
• Strong understanding of infrastructure qualification and performance qualification concepts
• Experience working in Agile / Scrum environments
• Proficiency in SQL / PLSQL writing
• Experience with electronic QMS/DMS systems
• Experience with manual validation execution and ALM tool-based testing
• Strong organizational, communication, and multitasking abilities
• Ability to balance quality and productivity effectively

About the Organization:
RxLogix is a leading provider of pharmacovigilance and drug safety solutions, delivering innovative software platforms and regulatory compliance services to life sciences organizations worldwide. The company focuses on quality, regulatory excellence, and advanced technology-driven safety solutions.