Overview

Reference Number: JO-2107-472570
Quality Business System Analyst
Rate: Negotiable
Job Type: Permanent
Location: Waterford

Quality Business System Analyst

6 month contract

Pay up to 180 per day

Waterford location

CPLare recruiting for a Quality Business System Analyst to join apharmaceutical company at their site based in Waterford on acontract basis for 6months.

The role is required to provide ongoing support and maintenance of Quality IT systems such as Phenix, DGBI, Geode+, Alexandria, Comet, SDMS, Caducee, and LUNA (LIMS).

The Quality Business Systems Analyst role provides support for Laboratory and Quality IT systems. Ensures that Quality IT systems are introduced, maintained / administered and used in a GxP compliant manner. Identifies and implement continuous improvements, regulatory requirements, best practices, and efficiencies.

Job Requirements

  • The Quality Business Systems Analyst role provides support for Laboratory and Quality IT systems (Deviations Management System, Documentum D2 Documentation Management System, Empower 3, NuGenesis 8 SDMS/ELN Sample Manager LIMS, Digital Tools).
  • Ensures that Quality IT systems are introduced, maintained / administered and used in a GxP compliant manner.
  • To map current and future state processes and to identify and implement continuous improvements, regulatory requirements, best practices, and efficiencies in a GxP manner.
  • User Access Management of Quality IT Systems.
  • Master Data and Change Management of Quality IT Systems.
  • Version Release Management of Quality IT Systems.
  • Interface management for systems within scope of role.
  • Technical / End User support for the Waterford site.
  • Generation and update of system related documentation e.g. Change Control, URS, Functional Specification, IQ, OQ, UAT, PQ, SOPs etc) and project execution to the required schedules as per the Site Digital/IT Roadmap.
  • Ensuring that systems and implemented and configured to position the site to take advantage of Digital and paperless opportunities.
  • Maintenance of key reporting tools and metrics.
  • Work with relevant cross-functional project teams and stakeholders on monitoring, reporting and analysis of key KPIs.
  • Ensure that systems in his or her area meets Sanofi corporate and manufacturing/laboratory site standards.
  • Execute system deployment / upgrade projects as per site ITS Roadmap.
  • Ensuring that Data Integrity and GxP compliance is maintained within the Quality IT Systems at all times.

If youre interested please apply or send your CV to luke.sandilands@cpl.com

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