Lab Software Application Specialist - temporary 12 months

Solvias

Kaiseraugst

Vor Ort

CHF 85.000 - 105.000

Vollzeit

Vor 4 Tagen
Sei unter den ersten Bewerbenden
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Zusammenfassung

Solvias seeks a Lab Software Application Specialist to translate, modify, maintain, and verify methods and report templates for Labware LIMS 7 and Chromeleon 7.3.2, focused on the upgrade from 7.2.10 to 7.3.2. One-year assignment in a collaborative QC/QA environment.

You will work with QA, IT, and SMEs to ensure data integrity, validation, and compliant documentation while building and maintaining templates across laboratories.

Qualifikationen

  • Degree in Analytical Chemistry, Pharmaceutical Sciences, or related field.
  • Experience with Chromeleon CDS.
  • Experience in method configuration and reporting.
  • Experience in system migrations preferred.
  • Exposure to CSV in GxP environments.
  • Strong CDS and chromatography knowledge.
  • Understanding of GxP and data integrity.

Aufgaben

  • Translate existing Chromeleon objects from version 7.2.10 into 7.3.2.
  • Maintain LIMS Master Data.
  • Assess legacy configurations and identify required adaptations.
  • Ensure functional equivalence and data integrity.
  • Execute controlled migration including testing.
  • Support migration within the upgrade program.
  • Create, modify, and maintain Chromeleon templates.
  • Ensure harmonization across laboratories.
  • Maintain template libraries and documentation.
  • Perform regular reviews for compliance and consistency.
  • Optimize templates for usability and efficiency.
  • Support validation of templates and methods.
  • Author and review validation documentation.
  • Execute test cases and document results.
  • Support deviation handling.
  • Process changes under formal change control.
  • Perform impact and risk assessments.
  • Ensure alignment with SOPs and governance.
  • Support documentation updates.
  • Serve as SME for Chromeleon templates.
  • Support troubleshooting.
  • Collaborate with QA, IT, SMEs.
  • Support training of end users.

Kenntnisse

Analytical mindset
Problem solving
Attention to detail
GxP knowledge
Workflow to configuration
CSV in GxP environments
Method configuration

Ausbildung

Bachelor's degree in Analytical Chemistry or Pharmaceutical Sciences

Tools

Chromeleon CDS

Jobbeschreibung

Job Description

The Lab Software Application Specialis is responsible for the translation, modification, maintenance, and verification of methods and report templates (Master Data) for Labware LIMS 7 and Chromeleon 7.3.2. The main duty falls in the roll out phase in the course of upgrading from Chromeleon 7.2.10 to 7.3.2. This position is limited for 1 year.

Responsibilities
Method & Template Migration
  • Translate existing Chromeleon objects from version 7.2.10 into 7.3.2
  • Maintain LIMS Master Data
  • Assess legacy configurations and identify required adaptations
  • Ensure functional equivalence and data integrity
  • Execute controlled migration including testing
  • Support migration within the upgrade program
Template Build & Maintenance
  • Create, modify, and maintain Chromeleon templates
  • Ensure harmonization across laboratories
  • Maintain template libraries and documentation
  • Perform regular reviews for compliance and consistency
  • Optimize templates for usability and efficiency
Validation & Documentation
  • Support validation of templates and methods
  • Author and review validation documentation
  • Execute test cases and document results
  • Support deviation handling
Change Control & Governance
  • Process changes under formal change control
  • Perform impact and risk assessments
  • Ensure alignment with SOPs and governance
  • Support documentation updates
Operational Support & SME Role
  • Serve as SME for Chromeleon templates
  • Support troubleshooting
  • Collaborate with QA, IT, SMEs
  • Support training of end users
Qualifications
  • Degree in Analytical Chemistry, Pharmaceutical Sciences, or related field.
  • Experience with Chromeleon CDS
  • Experience in method configuration and reporting
  • Experience in system migrations preferred
  • Exposure to CSV in GxP environments
  • Strong CDS and chromatography knowledge
  • Understanding of GxP and data integrity
  • Knowledge of change control
  • Ability to translate analytical workflows into system configurations
  • Analytical and problem-solving mindset
  • High attention to detail
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