Sr. eCompliance Specialist

Novartis AG; Hyderabad; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Novartis AG in Hyderabad seeks a Senior eCompliance Specialist to provide QA oversight for CSV and GxP regulated computerized systems within the Novartis Quality Manual framework. You will approve changes, deviations, CAPAs, and Periodic Reviews, and support IT–Business collaboration to ensure compliant operation of automation and AI-enabled solutions in day-to-day eCompliance activities.

The role requires 5–10 years of experience in the pharmaceutical industry, strong regulatory knowledge, and

Qualifications

• Experience with CSV/validation of computerized systems in regulated environments.
• Understanding of GxP requirements and 21 CFR Part 11 expectations.
• Strong collaboration across IT and Business for eCompliance topics.

Responsibilities

• Provide quality oversight for CSV activities and GxP systems.
• Review and approve GxP relevant project documents and determine applicability.
• Support CAPA, deviations, and Periodic Review processes.
• Contribute to VMP preparation and execution for relevant systems.
• Interface IT and business to promote a quality culture.

Skills

CSV knowledge

Quality assurance

Regulatory compliance

ITIL familiarity

GxP systems

Education

Degree in IT/Life Sciences/Pharmacy/Engineering

Tools

CAPA Management System

Periodic Review Tools

Job description

SummaryAbout the role:The Senior eCompliance Specialist is responsible for providing Quality Assurance oversight and guidance with regard to computerized systems validation (CSV), operating within the framework of regulations (GxP, 21CFR11, etc.) and requirements defined in the Novartis Quality Manual and global procedures.Sr. eCompliance Specialist provides the needed operational support such as approving the GxP impacted changes, Periodic Review Reports, deviations, etc.. Provides the guidance to the project and operations team on the CSV related topics and related information. Reviews and/or approves the global Computerized Systems key validation deliverables as a part of the eCompliance support to the GxP projectsAbout the RoleKey Requirements:Quality oversight of Project and operational activities of GxP systems (e.g.: changes, Periodic Reviews, deviations, etc.) Provide needed support to meet the applicable Novartis and regulatory requirements for GxP regulated computerized systems projects. Support the implementation, operation and optimization of automation and AI-enabled solutions in day-to-day eCompliance activities.Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture.Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems.Establish trusted partnership with assigned IT Function with understanding of business drivers, and provide the needed day to day operational support. Review and approve the GxP impacted deviations, ensure appropriate CAPA are implemented.Contribute for the preparation of VMP and execute the plan for the systems associated with the respective functions. Review and approve the Periodic Review Reports for the GxP computerized systems and the associated gaps within CAPA Management System.Perform supplier qualification assessment activities. Provides audit support as assigned and in case of CAPAs, provides the required Quality support.Essential Requirements:Degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent.5-10 years of overall experience, and a minimum 4 years of relevant experience in the Pharmaceutical Industry within particular in regulated functions such as IT Quality and ComplianceGood understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.)Good experience in the development, implementation and lifecycle management of computerized systems in regulated environmentsExperienced in the operational management of GxP solutions including its related technologies to support the operation. Experience in GxP supplier qualification activitiesDesirable Requirements:Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.)Experienced in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure spaceSuccessful cross-divisional/functional work with complex international teamsAbility to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitudeAbility to effectively interact and present to ManagementAbility to influence without hierarchical authority and build trusted partnershipsSelf-starter with experience in initiating and delivering projects and processesExcellent communication, negotiation, facilitation, and interpersonal skillsWhy Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureBenefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.Read our handbook (PDF 30 MB)DivisionOperationsBusiness UnitQualityLocationIndiaSiteHyderabad (Office)Company / Legal EntityIN10 (FCRS = IN010) Novartis Healthcare Private LimitedFunctional AreaQualityJob TypeFull timeEmployment TypeRegularShift WorkNoAccessibility and accommodationNovartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.