3 Gxp Processes Jobs

As a key resource within the Audit Management Office (AMO), you will ensure effective coordination and management of audits and inspections involving Data, Digital & IT (DD&IT) systems and processes. This includes supporting GxP audits (e.g., GMP, GCP) and regulatory inspections by authorities such as FDA, EMA, MHRA, and Swissmedic. Your role as an associate will involve acting as a liaison, ensuring that relevant DD&IT subject matter experts address audit queries and deliver required documentation in a timely and accurate manner. Additionally, you will be responsible for monitoring audit findings, overseeing remediations, and driving continuous improvement in audit readiness. Govern processes to effectively manage both internal and external audits across Data, Digital & IT (DD&IT), focusing on GxP (e.g., GMP, GCP), quality, and regulatory-related audits. Act as the single point of contact (SPOC) for audit teams across DD&IT, coordinating audit and inspection activities, ensuring effective communication, and maintaining compliance throughout the process. Notify and mobilize relevant DD&IT stakeholders for audits and inspections, ensuring timely readiness. Coordinate globally with business teams to ensure audit support tickets are created, tracked, and resolved in alignment with Novartis policies and procedures. Conduct pre-audit meetings to clarify IT scope, agree on auditor pre-requests, align timelines, and ensure stakeholders understand expectations for audits and inspections. Provide advice and guidance to DD&IT teams on GxP and information systems compliance requirements to ensure alignment with regulatory standards such as FDA, EMA, MHRA, and Swissmedic expectations. Guide DD&IT SMEs by clarifying audit process requirements and supporting them throughout the audit lifecycle, ensuring accurate delivery of requested information. Collaborate with internal teams to improve and standardize governance frameworks and processes, aiming to reduce audit findings and improve inspection readiness. Manage relationships at a global level across divisions and functions, facilitating cross-functional alignment and collaboration on audit-related matters. Monitor and report on audit findings, remediation actions, and related improvement activities, ensuring compliance, security, and quality gaps are addressed thoroughly. To be considered for this role, you should have a University degree or equivalent, with a Masters degree in IT, Quality Management, Business Administration, or related fields. You should have overall 8-10 years of work experience in quality management, audit, and compliance within IT, preferably in a global organization. Experience in the pharmaceutical industry or other regulated industries, with knowledge of GxP processes and compliance requirements, is required. Strong communication skills and the ability to manage multiple priorities efficiently are essential for this position. Join Novartis and be part of a mission to reimagine medicine and improve people's lives. Learn more about our commitment to diversity and inclusion and explore the opportunities available within our network.,

The Data Warehouse Engineer will be responsible for managing and optimizing data processes in an Azure environment using Snowflake. The ideal candidate should have solid SQL skills and a basic understanding of data modeling. Experience with CI/CD processes and Azure ADF is preferred. Additionally, expertise in ETL/ELT frameworks and ER/Studio would be a plus. As a Senior Data Warehouse Engineer, in addition to the core requirements, you will oversee other engineers while also being actively involved in data modeling and Snowflake SQL optimization. You will be responsible for conducting design reviews, code reviews, and deployment reviews with the engineering team. Familiarity with medallion architecture and experience in Healthcare or life sciences industry will be highly advantageous. At Myridius, we are committed to transforming the way businesses operate by offering tailored solutions in AI, data analytics, digital engineering, and cloud innovation. With over 50 years of expertise, we aim to drive organizations through the rapidly evolving landscapes of technology and business. Our integration of cutting-edge technology with deep domain knowledge enables businesses to seize new opportunities, drive significant growth, and maintain a competitive edge in the global market. We go beyond typical service delivery to craft transformative outcomes that help businesses not just adapt, but thrive in a world of continuous change. Discover how Myridius can elevate your business to new heights of innovation by visiting us at www.myridius.com and start leading the change.,

As a Data Warehouse Engineer at Myridius, you will be responsible for working with solid SQL language skills and possessing basic knowledge of data modeling. Your role will involve collaborating with Snowflake in Azure, CI/CD process using any tooling. Additionally, familiarity with Azure ADF and ETL/ELT frameworks would be beneficial for this position. It would be advantageous to have experience in ER/Studio and a good understanding of Healthcare/life sciences industry. Knowledge of GxP processes will be a plus in this role. For a Senior Data Warehouse Engineer position, you will be overseeing engineers while actively engaging in the same tasks. Your responsibilities will include conducting design reviews, code reviews, and deployment reviews with engineers. You should have expertise in solid data modeling, preferably using ER/Studio or an equivalent tool. Optimizing Snowflake SQL queries to enhance performance and familiarity with medallion architecture will be key aspects of this role. At Myridius, we are dedicated to transforming the way businesses operate by offering tailored solutions in AI, data analytics, digital engineering, and cloud innovation. With over 50 years of expertise, we drive a new vision to propel organizations through rapidly evolving technology and business landscapes. Our commitment to exceeding expectations ensures measurable impact and fosters sustainable innovation. Together with our clients, we co-create solutions that anticipate future trends and help businesses thrive in a world of continuous change. If you are passionate about driving significant growth and maintaining a competitive edge in the global market, join Myridius in crafting transformative outcomes and elevating businesses to new heights of innovation. Visit www.myridius.com to learn more about how we lead the change.,