Job Description
Overall responsibility for maintaining and supporting the quality control (QC) computerized lab quality systems application/software as Lab Supporter 2/3 Level.
• 2/3 level support Analytical Instrument Application/Software • Incident resolution (trouble shooting, physical check of instrument, network issue, licenses configuration, data flow and data storage issues…)
• User Administration (User creation, access, check on validity of user accounts…)
• Periodic reviews and maintenance (support client instrument owner, ensure maintenance plan is in place and followed, support firmware updates…)
• Analyze and troubleshoot hardware, software, and network-related problems relying on proven techniques for analysis and evaluation
• Set up, configure, troubleshoot, and maintain QC and manufacturing lab quality systems, ensuring compliance with FDA standards and industry best practices surrounding CFR 21 Part 11 and Annex 11 regulations
Requirements
• University Degree (or qual) in associated field and 3+ years’ experience in a GxP regulated environment
• Understanding of GAMP 5 framework
• Understanding of CFR21 Part11 & EU Annex 11
• Understanding of Computer System Validation (CSV)
• Thorough knowledge of Windows XP, 7, and 10, Server 2008, 2012, and 2016, Active Directory, storage and backup devices, VMWare, Routers, Switches and other solutions
• Knowledge in server, storage and virtualization standards, techniques and tools.
• Knowledge and support of standard software packages including Microsoft Office and Adobe productivity tools
• Strong written & verbal communication.
• Effectively collaborate with peers, cross-functional teams and users across the organization to achieve end-to-end product and process quality
• Strong Analytical/problem solving and organizational skills
• English (fluent in spoken and written)
• 100% On-Site 8:00AM – 05:00PM
Requirements
Overall responsibility for maintaining and supporting the quality control (QC) computerized lab quality systems application/software as Lab Supporter 2/3 Level. • 2/3 level support Analytical Instrument Application/Software • Incident resolution (trouble shooting, physical check of instrument, network issue, licenses configuration, data flow and data storage issues…) • User Administration (User creation, access, check on validity of user accounts…) • Periodic reviews and maintenance (support client instrument owner, ensure maintenance plan is in place and followed, support firmware updates…) • Analyze and troubleshoot hardware, software, and network-related problems relying on proven techniques for analysis and evaluation • Set up, configure, troubleshoot, and maintain QC and manufacturing lab quality systems, ensuring compliance with FDA standards and industry best practices surrounding CFR 21 Part 11 and Annex 11 regulations Requirements: • University Degree (or qual) in associated field and 3+ years’ experience in a GxP regulated environment • Understanding of GAMP 5 framework • Understanding of CFR21 Part11 & EU Annex 11 • Understanding of Computer System Validation (CSV) • Thorough knowledge of Windows XP, 7, and 10, Server 2008, 2012, and 2016, Active Directory, storage and backup devices, VMWare, Routers, Switches and other solutions • Knowledge in server, storage and virtualization standards, techniques and tools. • Knowledge and support of standard software packages including Microsoft Office and Adobe productivity tools • Strong written & verbal communication. • Effectively collaborate with peers, cross-functional teams and users across the organization to achieve end-to-end product and process quality • Strong Analytical/problem solving and organizational skills • English (fluent in spoken and written) • 100% On-Site 8:00AM – 05:00PM