Novartis BSc Specialist Job Opening – Apply Online
Sr. eCompliance Specialist
Job ID: REQ-10026554
Date: Oct 21, 2024
Location: India
Summary
The Senior eCompliance Specialist is responsible for providing Quality Assurance oversight and guidance on computerized systems validation (CSV), working within regulatory frameworks (GxP, 21CFR11, etc.) and adhering to standards defined in the Novartis Quality Manual and global procedures.
The Sr. eCompliance Specialist provides operational support, including approving GxP-impacted changes, Periodic Review Reports, deviations, etc., and offers guidance to the project and operations teams on CSV-related topics. This role also reviews and/or approves key validation deliverables as part of the eCompliance support for GxP projects.
About the Role
Major Accountabilities:
- Quality oversight of project and operational activities of GxP systems (e.g., changes, Periodic Reviews, deviations) to meet Novartis and regulatory requirements for GxP-regulated computerized systems projects.
- Act as the point of contact for all CSV-related matters for GxP Computerized Systems and interface between IT and Business for eCompliance topics, promoting a Quality Culture.
- Review and approve project-related documents for GxP-relevant systems, including determining GxP applicability for all GxP and non-GxP systems.
- Establish trusted partnerships with assigned IT functions, understanding business drivers and providing necessary day-to-day operational support.
- Review and approve GxP-impacted deviations and ensure appropriate CAPAs are implemented.
- Contribute to the preparation of the Validation Master Plan (VMP) and execute the plan for systems associated with respective functions.
- Review and approve Periodic Review Reports for GxP computerized systems and address gaps within the CAPA Management System.
- Perform supplier qualification assessment activities.
- Provide audit support as assigned and deliver required Quality support in case of CAPAs.
Key Performance Indicators:
- GxP-relevant computerized systems are developed, implemented, and maintained according to Novartis requirements.
- Timely review and approval of changes, deviations, and periodic review reports for GxP computerized systems.
- Documentation supporting eCompliance and CSV requirements is maintained up-to-date and can be presented during audits and inspections without delays or issues.
- Gaps in eCompliance and CSV activities are proactively identified, escalated, and supported with the development of mitigation plans.
- Client/stakeholder satisfaction and corresponding feedback.
Minimum Requirements:
Work Experience:
- 5-10 years of overall experience, with a minimum of 4 years in the Pharmaceutical Industry, particularly in regulated functions such as IT Quality and Compliance.
Skills:
- Strong understanding of global regulations and Health Authorities’ expectations governing computerized systems (CSV, Part 11, etc.).
- Experience in developing, implementing, and lifecycle management of computerized systems in regulated environments.
- Expertise in operational management of GxP solutions, including related technologies to support operations.
- Experience in GxP supplier qualification activities.
- Knowledge of system application management, Quality support approach, and industry best practices (ITIL, ITSM, etc.).
- Experience with key computerized systems in Pharmaceutical Development, Manufacturing, Quality, Commercial, and Infrastructure.
- Proven success working with complex, cross-divisional/functional international teams.
- Ability to adapt to multiple demands, shifting priorities, and unexpected events with a positive work attitude.
- Effective interaction and presentation skills for management.
- Ability to influence without hierarchical authority and build trusted partnerships.
- Self-starter with experience initiating and delivering projects and processes.
- Strong communication, negotiation, facilitation, and interpersonal skills.
Education:
Minimum/Desirable: Degree in Information Technology, Life Sciences, Pharmacy, Engineering, or equivalent.
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Keywords: eCompliance Specialist, Quality Assurance, Computerized Systems Validation, GxP Regulations, Pharmaceutical Industry. Novartis BSc Specialist Job Opening – Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
