QC Specialist

Job Description

This position will be part of the Technical Services team building the BAU model to support Quality and Manufacturing in an efficient and agile manner. The Role is primarily responsible for the day-to-day support of the site LIMS System and GMP Process associated with the generation and maintenance of GMP Master data, as well as support the site end-user operational needs as required. Responsibility for the day-to-day maintenance of gLIMS, including but not limited to:

Data to Day operational Master data activity

Receiving, tracking and completing all gLIMS actions on QTS in a timely manner.

Building all Masterdata in accordance to gLIMS Master Data Configuration Standards (CD-(phone number removed & gLIMS Master Data SOP-00671.

Completing all gLIMS verification testing using ALM in accordance to the global SOPs.

Complete all defect management in ALM for all Master Data Objects.

Site POC for all gLIMS queries and troubleshooting, resolving where possible or escalating to the appropriate external team when necessary.

Support the Environmental module and associated periodic trend reports

gLIMS Application Releases

Assess all releases (major & minor) using the release notes issued and attend any release note meetings.

Represent the site on release note meetings, User council meetings etc.

Participate in all meetings to ensure sites needs are raised in the correct forum

Perform Periodic Review and UAR for gLIMS as required

Support data integrity audits and other Regulatory audits as required

Raise enhancements to the gLIMS as needed by site.

Support Core testing and design of future enhancements.

SOPs & Training

Maintain gLIMS SOP's in an effective state

Deliver site training on all gLIMS modules to end users withing scope of you Job role.

Work with BTAMS for account creation, modification and revoking.

Additional Responsibilities

Empower Master Data creation

Help with computer software management in the QC Lab