Solution Assurance Expert

314634BR
May 18, 2021
Czech Republic

Job Description

Solution Assurance Expert, Novartis, Prague, Czech Republic

200+ Web, Social and Mobile Applications implemented using cutting edge technologies and tools; used by our clients and patients; responsible to assure the implemented systems are compliant with global standards & procedures and are smoothly transitioned to servicing organization


On this role you will be responsible for coordination, control and monitor changes to the systems environment for an IT operational area to ensure operational stability. Plan and execute service transitions. Manage the software change cycle and ensure maintenance of the service catalog to reflect changes.

Your key responsibilities:
Your responsibilities include, but are not limited to:

• Lead project compliance work streams and responsible for end to end quality and compliance aspect of the project and qualification/validation deliverables and perform qualification/validation impact analysis and risk assessments, both high level and functional, to ensure requirements coverage.
• Manages compliance of the system during its lifecycle, with regards to Regulatory and Novartis Internal Standards. This is performed through document reviews & coordination of various activities including testing, performing Project Tollgates etc.
• Author key qualification/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.
• Responsibility for tracking, monitoring and controlling validation process to ensure timely and cost-effective delivery of the system to the business users.
• 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

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
CTS
IT NBS
Czech Republic
Prague
Information Technology
Full Time
Regular
No
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314634BR

Solution Assurance Expert

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