This role will be responsible for monitoring day-to-day usage operation and maintenance of computer systems. Job responsibilities include but are not limited to implementing and maintaining controls, processing and documentation to provide: confidentiality, integrity, availability, compliance and reliability of computer systems to support business operations.
•Support the transition and handover of Projects with key stakeholders
•Maintain system documentation and process according Novo Nordisk standards and in compliance with regulatory requirements in a structured way to facilitate rotation and consequently support the transition of systems from System Manager to System Manager
•Collaborate with project managers to define interface agreements, service level agreements (SLAs) and proper change management to move systems to operations
•Support daily IT Operations including but not limited to: general support; vendor management; change and release management; archiving and retention of computer system documentation and data; risk management and security; validation and training
•Provide follow-up on Incidents, Service Requests, Problems, Change Requests and Remarks/NCs. Ensure communication, action and escalation on issues that impact system Confidentiality, Integrity, Availability, Compliance and Reliability
•Maintain list of IT vendors/suppliers including the criticality of the hardware, software and critical infrastructure for computer systems
•Coordinate with IT Manager on vendor Service Level Agreements regarding system support
•Follow-up on vendor deliveries and services according to agreements
•Maintain SLA’s and IT Service catalog
•Ensure proper documentation, testing, communication and stakeholder management for changes
•Provide continuous follow-up on system component life-cycle ensuring proper maintenance and system strategy
•Archive and retain documentation and data according to requirements
•Assist risk management work in cooperation with stakeholders and department manager
•Support disaster recovery documentation and proper test and training of stakeholders
•Support required controls to ensure system security
•Ensure that the systems are in compliance with relevant internal and external requirements (cGMP, 21CFR Part 11 and overall instructions)
•Support audits and inspections and provide the needed documentation to demonstrate validation state and proper management of the systems though the life-cycle
•Create and maintain system documentation for GxP computer systems
•Test IT requirements for GxP computer systems
•Perform, prepare and maintain training material, including but not limited to SOPs, Guidelines and class training material
•Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
•Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others
This position may lift up to 33 pounds occasionally, and/or up to 10 pounds frequently or constantly to lift, carry, push, pull or otherwise move objects. Repetition including substantial movement of wrists, hands, and or fingers. The ability to speak, listen, and understand verbal and written communication. The ability to stoop, kneel, crouch, reach, stand, and walk. The ability to push, pull, lift, finger, and grasp. Visual acuity to perform close activities such as: reading, writing, and analyzing; operating a motor vehicle or heavy equipment, and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations. The working environment includes a variety of physical conditions including: noise, inside and outside conditions including temperature changes; atmospheric conditions including: odors, fumes, and dust. Local and International Travel: 0-5%.
•Bachelor’s Degree in relevant field (Computer Science or equivalent)
•IIBA Certification ECBA or CCBA preferred
•Minimum 3 years’ experience on operation and maintenance of IT systems, preferably within the pharmaceutical industry
•Experience with validating and qualifying IT systems in GxP and non GxP environments, performing and executing validation documentation and testing protocols (IQ/OQ/PQ/UAT)
•Excellent writing and communication skills, in English
•Strong ability to collaborate effectively in a team environment
•Excellent problem solving, negotiation, conflict management, and interpersonal skills
•Excellent planning, organizing, decision making and deal with ambiguity
•Strong computer skills and MS Office Expert
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