Purpose of Role
– Provides support in the process of creating the documentation specific to computerized systems: validation plan, user requirements, software and hardware configuration design documents.
– Creation of documentation associated with establishing the qualification status of production and laboratory equipment. This includes installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) documents.
– Be the site responsible for delivering, supporting and managing Quality systems and solutions in the laboratories and production area. These systems maybe standalone or interfaced with other systems.
– To be the site expert on all laboratory computer systems – LIMS (Labware), CDS (Empower), standard-alone computer driven instrumentation and other applications identified by laboratory management.
– To manage and support standalone Laboratory / Quality systems, maintaining support for Interfaces and troubleshooting as and where required.
– Maintain the integrity of these systems and ensuring backup up solutions are in place by the global or local ITMU’s using standardised solutions.
– To ensure sufficient consideration is paid to all regulatory compliance requirements for system implementation and maintenance including cGMP, computer systems validation, security and risk. Assist in the generation and execution of validation deliverables.
– To ensure appropriate service levels are developed and monitored, for support of laboratory IS systems working with the global team, external partners and providers of specific software related to the labs. Ensure support partners perform to the defined SLA and provide resolutions within the agreed timescales.
– Exchange and fix infrastructure compoments in the respective area
– Coordinate between business / IT stakeholder management and global ITO teams
– Contribute to a continous documentation of the system landscape in the respective area
– Provide technical support as point of contact for IT for the site.
– New users onboarding preparing IT assets and tools.
– End-user desktop, laptops, office IT support. Installation support for various software on end user systems and equipments when required.
– Onboarding and mentoring of external IT Operations onsite engineers
– Offboarding support, collecting IT assets and sanitizing IT assets and keep in stock.
– Handling tickets on the internal Ticketing system (ServiceNow) platform.
– IT Asset Management. Manage Hardware rollouts.
– Perform troubleshooting, parts replacement, system upgrades, and basic deployments and repair on sites where required.
– IP phone, Video conference support, Printers support.
– Basic installation and maintenance of technical products.
– Installs, maintains, and optimizes desktop /notebook configurations. Reviews, troubleshoots, and approves operational quality desktops, notebooks, printers, and associated peripherals.
– Ensure that all work carried out is in compliance with the required standards conforming to company cGMP, cGLP, SOP, Health & Safety Specifications, Environmental and Regulatory requirements.
Knowledge, Skills and Abilities
– IT Business experience with desktop, mobile computing and/or network, including problem analysis/resolution, and installation.
– Experience across a broad range of Quality / Laboratories systems and applications in the Pharmaceutical Industry.
– Knowledge of Microsoft Windows OS, Network equipments, Internet connectivity and knowledge of computer networking / server and compute environments.
– Knowledge of PC Hardware configurations and troubleshooting
– Strong written, numerical and verbal communications skills. Compliance, Validation GxP experience.
