CSV & TECHNOLOGY SPECIALIST

Summary Execute activities related to GxP computerized systems implementation, validation, and related activities, as well as data and user access management in ERP systems (such as SAP) in accordance with local, regional, and global standards and guidelines.
Coordinate and execute tasks related to regional processes, procedures and life cycle management activities of analytical technology implemented for drug products analysis and control, guaranteeing fulfilment of local, regional and global quality standards.
About the Role General Guarantee region DI and GxP compliance according to current health authorities’ regulations and applicable guidelines as well as corporate standards.
Assist and support internal and external audits.
Establish and verify timely execution of all CAPAs derived from these audits.
Collaborate in appropriate resolution of all deficiencies detected during health, internal, corporate and security authorities’ audits.
Actively participate in initiatives and projects to improve Quality Assurance at a local, regional and/or global level.
Participate in the strategy and actions for regional projects of Quality Assurance Digital Solutions, in order to create a more productive and efficient environment in QC laboratories, in accordance with Novartis' general Digital QC strategy.
Identify, and propose solutions directed to mitigate data integrity risks throughout analytical technology use.
Demonstrate customer-oriented service mindset in handling and executing deliverables.
Responsible for data compilation and preparation of dashboard/data bases on regular basis to track and report deliverables.
Report and record Issues, Deviations, Quality Events emerging from process delivered, and communicate progress as appropriate in collaboration with team leader.
Ensure efficient, timely and clear communication to all involved partners (local and global functions) as required for follow-up on activities under scope.
Build and maintain high expertise and continuously acquire process knowledge.
Support and participate in the implementation and modification of processes.
Computerized systems validation Collaborate with local quality control laboratories in conception and execution of validation programs for computerized systems, and related activities.
Create, and/or review validation protocols and reports for QC laboratories computerized systems, warranting a consistent and compliant approach throughout the region.
Execute tasks related to computerized systems administration, in collaboration with the System Owner, such as User Administration, Periodic User Review, Audit Log review, etc.
Technology Lifecycle Manage electronic data backup and restoration processes with local/regional IT teams, in accordance with ISRM guidelines and Effective Procedures.
Create, manage and implement the strategy for regional Quality Assurance investment projects, effectively coordinating the necessary documentation among the Laboratory Services center, the end user, Procurement, QA, etc.
Identify and prioritize the critical requirements of regional Quality Assurance and its Quality Control laboratories, optimizing the assigned regional CapEx budget.
Lead and coordinate with local QC laboratories and AS&T teams, the implementation of analytical technologies, effectively coordinating all necessary documentation, such as risk assessments, change controls, etc., ensuring a standardized approach throughout the region.
Collaborate with local QC laboratories in the creation and execution of Validation programs for analytical technology and computerized systems.
Collaborate with Procurement and the Laboratory Supplies Center (Hub) in the creation and negotiation of contracts for Equipment Services with third-parties.
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