Role Description:
Lab
IT
Administrator role whose primary responsibility will be to work with
Lab
COE and local site DMO team to provide end-to-end support for the Business users & Stakeholders, Coordinate with Site for technical topics, Coordinate with Support team, etc..
Role Functions
(Functions include, but are not limited to, the following)
:
* As a Lab IT Administrator, you are responsible for providing hands-on end-user support, administration, and issue resolution for GxP-controlled laboratory equipment, servers, desktops, and software packages.
* Troubleshoot and resolve complex laboratory technical issues involving software, OS, hardware, network, or scientific equipment setup/interfaces.
* Execute routine system administration and maintenance activities as required.
* Ensure proper user management process is adhered to for all computerised systems
* Administer lab system access requests
* Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
* Assist systems users with defining, authoring, and documenting system use in user, admin, and maintenance SOPs
* Ensures systems comply with 21 CFR Part 11 Electronic Records and Electronic Signature requirements, as well as requirements from EU Annexe 11 and all Data Integrity standards and guidelines. Ensure applicable standards and specifications are adhered to.
* Work closely with CSV Lead, System Integrator and Site IT Team.
* Work with the operational readiness team and operations to ensure acceptable turnover.
* Provide support during internal and agency inspections.
* Support subject matter expert (SME) for general troubleshooting, problem solving, technical direction and guidance to support overall business needs
* Take ownership of related tasks, work under minimal supervision, utilise the industry experience and best judgment to make tactical decisions, stay proactive, etc.
* Advanced knowledge of system vulnerabilities and security issues.
* Monitor the system daily and respond immediately to security or usability concerns.
* Create and verify backups of data
* Respond to and resolve help desk requests
Qualifications & Education:
* Bachelor's Degree or Higher in a technical discipline
* 5+ years of professional experience in the digital space
* Excellent communication skills (written and oral).
* Ability to multitask and handle tasks with competing priorities effectively.
* Experience identifying operational issues and recommending and implementing strategies to resolve problems
Desired Qualifications:
* At least 3 years of experience working in a similar position within a GxP-regulated environment
* Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems is required, including the authoring of end-to-end of life cycle documents (including systems use and administration procedures)
* An understanding of Data Integrity concepts is required
* Excellent communication and written skills required