About Novartis
One of the largest pharmaceutical company of swiss origin located in Basel, Switzerland. Originated by merging of Ceiba and Geigy in 1996.The company further classified its operations to 3 major divisions: Sandoz (generics), Alcon (eyecare) and innovative medicines, it has 33.3% ,24.9% of the Roche shares and identic pharma respectively. The firm established its Multi functional center in Hyderabad, which covers of around 870,000 Square feet.
The pharma giant has a large portfolio of medicines in treating areas including but not limited to osteoporosis, Psoriasis, COPD, Hypertension, Alzheimer’s disease, heart failure, malaria, Amoebiasis, Asthma, schizophrenia and so on. This laid its step in animal health division, pests and rodent control by providing many varieties of products like milbemax, interceptor, Acara.
United states department of Health and human services in the year 2009, awarded Novartis with $ 486 contract for producing cell based influenza vaccine with a motto of 150,000,000 doses of flu pandemic vaccines with in 6 months. When gone through the financial aspect, it has a revenue of $ 53 billion and market capitalization of over $ 209 billion.
Recently decoding the hand of Artificial intelligence around pathological cancer, by recognizing the cancer at various stages. The firm has huge corporate responsibility helping in addressing the needs of undeserved populations, 24 Million patients reached access through the programs in 2018 and over 17 Million people reached training, health education services.
About the Job
Experience required : 5-10 years experience and a minimum of 4 years relevant experience in pharma IT industry related to IT Quality and Compliance.
Need to have good understanding of global and regulations governing CSV, 21 CFR part 11
Candidate provides the needed operational support such as approving the related GxP impacted changes, deviations, Periodic Review Reports, etc.
Required to have experience in handling various CSV projects in relation to the development, implementation and life cycle management of computerized systems.
Single point of approach for all CSV related matters for GxP Global CSV and act as an interface between Business for eCompliance topics and IT, in relation to GxP classified Computer Systems by promoting a Quality Culture
Should be able to Review and approve project related documents for Local and Global GxP relevant systems including the evaluation and determination of GxP applicability for all local and Global GxP and non-GxP relevant systems
Able to Contribute for the preparation of actions like VMP and execute the plan for the systems associated with the respective functions.
Perform the Quality oversight of Project and operational activities of GxP systems (e.g.: deviations, changes, Periodic Reviews, etc.)
Periodical Review and approve the Reports for the GxP computerized systems and handle the associated gaps within CAPA Management System. continuously handle the audit support as assigned and in case of CAPAs, provides the required Quality support.
Handle and perform Reviews and/or approves the global Computerized Systems key validation deliverables as a part of the objectives like eCompliance support to the GxP projects
Support the colleagues and provide needed support to meet the applicable Novartis organization and regulatory requirements those are required for GxP regulated computerized systems projects.
Sr. eCompliance Specialist required to Provides the guidance to the project team on the CSV related topics and related information.
The respective eCompliance Sr. Specialist is responsible for providing related Quality Assurance oversight and guidance with regard to task associated with computerized systems validation (CSV), operating within the framework of regulations (GxP, 21CFR11, etc.) and requirements defined in the Novartis Quality Manual and global procedures.
Handling of the Review and approval of the GxP impacted deviations, ensure appropriate CAPA are implemented.