Singapore Job Openings
Lonza
Systems Specialist 3, Quality Control
Tuas
FULL TIME
October 11, 2024
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Support and administration (system back-up, user access administration) for Sample Manager LIMS, MODA LIMS, i LAB, and other related Laboratory computerized systems
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Maintenance of LIMS static data (Sample Manager LIMS, MODA LIMS and STATISTICA systems)
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Support for installation and qualification/ validation of software related aspects of computerized instrumentation
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Actively contributes to operational efficiency/continuous improvement initiatives.
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Support system audit trail review all related Laboratory computerized systems
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Maintenance of software related changes to computerized instruments
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Server and database maintenance and administration as relates to laboratory systems
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Provide training for the roll-out of new computerized systems.
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Generation and execution of computer validation documentation (protocols and reports)
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Can identify computer related issues; troubleshoot, identify and complete or coordinate deviation, change control and/ or corrective action records.
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System/ equipment manufacturer and or vendor interaction as required in order to trouble shoot system issues.
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Available to troubleshoot and resolve critical system issues as they occur.
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Experience manages projects (people/ team environment) to meet the timelines.
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Customer and regulatory agency interaction as required.
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Oversight of computer system policies and procedure in order to ensure policy is aligned with current regulatory expectations.
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Familiarity with 21 CFR Part 11 and EU Annex 11 requirements, data integrity requirements and expectations as well as common industry practice with respect to laboratory computerized system management and administration.
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SME in 1 or more areas as aligned with training plan.
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Degree/Diploma in relevant Science field or Equivalent
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Minimum 5 years of experience
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Relevant work experience preferably Lab related IT experience in a biotech or medically related field.
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Experience in lab computer systems essential (prefer experience with LIMS, and CDS –Chromatography Data Systems
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