General Requirements
Able to provide LIMS technical support in a GMP regulated environment. General working knowledge of laboratory testing processes and documentation. The role requires troubleshooting and communication skills, initiative, determination and responsibility.
Responsibilities Include But Not Limited To
* Manage and complete all Support tickets in a timely manner related to troubleshooting at the application level, errors, user configuration, user creation, deletion.
* Work directly with level 3 administrators to resolve any issues/requests escalated to the Level 3 team.
* Contribute to the support and maintenance of operating procedures (SOPs and Work Instructions) pertaining to LIMS by reviewing updates to documents as requested by the validation lead/system manager.
* During LIMS upgrades and/or enhancements, perform development testing and support user acceptance testing, and upgrades.
* Identify opportunities for improving LIMS functionality and performance and provide recommendations to the system manager.
* Identify opportunities for streamlining LIMS business processes to improve efficiency and compliance and provide recommendations to the system manager.
* Maintain the LIMS system in a state of GMP compliance to ensure data integrity by following all related SOPs as they pertain to support duties.
* Perform LIMS maintenance tasks including:Account maintenance, periodic review of account and System Audit Trail and server maintenance.
* As a Support Engineer, provide support with LIMS system in GxP environment.
* Experience in service desk tools such as ServiceNow.
* Experience in Citrix Receiver, XenApp platforms.
* Good understanding of Active Directory, SharePoint.
* Take ownership of incidents and service requests and work to resolve them to user satisfaction while adhering service-level agreements.
* Regularly compile and provide metrics on incidents and service requests, trends to management.
* Skills:
* Good understanding of Laboratory Informatics Systems and business processes.
* Excellent verbal and written communication skills.
* Experience working in Pharmaceutical R&D, QC laboratories is a plus.
Mandatory Knowledge, Experience And Skills
* Fluency in English language both written and oral is imperative
* Excellent communication skills with the ability to support clients remotely
* Good understanding of PC hardware and use of Windows and Microsoft office including Excel
* Bachelor's degree in Science for Chemistry, biology or physics or a mathematical subject.
* 1 - 3 years' experience using the functionality of at least one of the Lab Information Systems such as Empower, LIMS, BIOVIA& LES, Veeva Vault in the pharmaceutical or related industry.
Preferred Experience
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Experience in Quality Control laboratory environment.Good working knowledge of laboratory testing processes and automation using various instrument software packages. Including the understanding of analytical chemistry and instrumental analysis. Displayed hands-on proficiency and problem-solving skills with chromatographic techniques.
Ø Certification or Knowledge of Current Good Manufacturing Practice, FDA 21 CFR Part 11, and EMA EU GMP Annex 11: Computerized systems
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Understanding and certifications of ITIL framework
Ø Microsoft Windows software and network certifications
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Experience in adhering to System Support KPIs