Specialist DDIT ISC QNova - Hyderabad, India - Novartis

Description

Location :
#L1 HybridThe purpose of the role is to deliver Quality management services to the NBS IT division and its Customers to ensure that information assets are adequately protected and compliant. The Project Quality Manager will ensure alignment and adherence across the IT, business, service provider and other stakeholders on quality and compliance for the IT projects.

Your responsibilities include but not are limited to:

• Perform validation impact analysis and risk assessments, both high level and functional, to ensure requirements coverage. Author key validation deliverables, provide GxP related validation expertise and partner with key business stakeholders (i.e. Manufacturing, Quality, Validation, Risk and Compliance, etc.) in defining the CSV strategy.
• Should be thorough with Document Management processes i.e. create, review, update and approve CSV deliverables including Validation Assessment, Validation Plan, Test Plan, Qualification scripts (IQ, OQ, PQ), Test protocols and reports, Traceability Matrix and Validation Summary Report.
• Experience of SDLC (Waterfall or Agile methodologies or DevOPS) and responsible for tracking, monitoring and controlling validation process to ensure timely and cost-effective delivery of the system to the business users.
• Ensure implementation and monitoring of IT compliance, records management and information risk management during IT projects, to ensure the integrity, confidentiality and availability of information owned, controlled or processed by the organization.
• Evaluates the risks arising from control deficiencies, gaps and facilitates risk mitigation planning. Supports Audits, Inspections and Assessments performed by internal and external agencies.
• Manage appropriateness of preparation and readiness of the project for handover of the system/processes to the operational organization together with the project managers. First point of contact for all quality related queries on the projects, follow-up resolution of identified quality exposures and escalation to line management if critical situations are not resolved in due course.
• Ensure adequate analysis have been performed for relevant testing conditions based on functional risk assessment, test overview list, test plan, test results, test deviations and change requests.
• Identify and log issues found during validation execution, perform root-cause analysis to define corrective and preventive measures to be taken and work closely with relevant product teams to prioritize and track validation incidents to closure.
• Strong hands - on experience in Development and Automation of Integration Solutions like EDI, API Management , Data Virtualization and (MFT) Managed File Transfer using products like IBM SI, AxwayB2Bi, APIGW and MFT and TIBCO's Data Virtualization
• Development experience in any Cloud technology AWS, Azure or GCP
• EDI Integrations design and development and providing Technical Support to the team.
• Strong hands - on technical experience in managing platforms preferably on Linux OS and expertise in DevSecOps tool stack ( Jenkins, Artifactory, Ansible