Process and Master Data Governance Manager 1

Sanofi•Swiftwater, PA

2d•Onsite

About The Position

The Lab Information Management System [LIMS] Business Administrator is essential to Quality Operations at the Swiftwater site for supporting the maintenance and improvement of the LIMS system. Maintenance support will include supporting the Business by updating master data for new and existing products, updating master data for new and existing analysis, maintaining system documentation, and providing ad hoc support to other departments. Support the creation of updating master data (Product, Item code and Sampling plan) in support of data remediations and SPC projects.

Requirements

1-3 years of experience in use and administration of a LabWare LIMS including LIMS Basic
Strong working knowledge of laboratory processes including cGMP s in a pharmaceutical environment
Experience in system validation, and master data management
Familiar with 21CFR part 11 data integrity best practices in pharmaceutical environment
Excellent written and verbal communications skills and the ability to lead and participate in teams

Nice To Haves

Experience with SQL and database structures

Responsibilities

Ensure site on-time implementation of data remediation activities through support of master data configuration and data migration and SOP revisions
Responsible for the master data management process including the updating of specifications, and analysis and supporting the approval and verification process
Ensure that the LIMS complies with all relevant regulatory standards
Support the business in the creation and updating of training materials as changes to system occur