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QC officer

Introduction


Just graduated and looking for a first opportunity? Interested to start your career as a consultant at XPE Pharma & Science? We are looking for a QC Officer.


Company/Department


The objectives of the Paperless Program in QC is to achieve paperless operations in GSK Vx QC laboratories by the following:

• Addressing gaps associated with Data Lifecycle Management / Data Integrity

• Within QC laboratories by implementing a Laboratory Execution System (LES)

• Within QC laboratories by implementing a Scientific Data Management System (SDMS) for analytical equipment

• Within Manufacturing by implementing an electronic samples tracking in SAP This program is global (covering GSK Vaccines manufacturing sites where QC activities are performed).

In order to achieve this, there is a need to harmonize practices and deploy pre-requisites for Chromatography Systems.

You will be responsible to :

- Develop and support the validation of custom fields, validity criteria and methods report template in Empower Software.

- Support the deployment of a One-CDS solution in some GSK Vaccines sites. This solution already exists in GSK (GMS sites) and is deployed in ~70 non GSK Vx sites.

- Support the implementation of interface between Empower and other systems (SDMS & LES) This role requires technical capability in Empower as well as Project Management/coordindation

and efficient communication capabilities.


Function information


• Support/guide laboratories in the development of specifications for the Custom calculations/validitycriteria/reports for the test methods in scope of this change.

• Develop and support validation in Empower Software of Custom field and Report

• Coordinate for methods under her/his scope the implementation of the new custom fields, reports … (“go-live”)

• Learn the process for the deployment of One-CDS from GMS and implement it with the GSK Vx sites in scope of One-CDS implementation. For each site, develop and follow a plan with the sites, monitor risks, report progress and escalate issue(s) to the appropriate Governance. Some travel to sites might be required.

• Contribute to the development of new processes and training material

• Efficiently train people (French and English) on the new system/processes.

• Support the implementation of interface between Chromatography Data Systems and SDMS-LES



Requirements


Education

• Have a graduate or master degree scientific or equivalent by experience

Knowledge

Empower software (experience using the system, already developed custom fields)

• Strong communication and engagement skills

• Pro-active, autonomous, stress resistant

• Hands-on mentality, eye for details

• Ability to work in project teams in a multidisciplinary environment, a matricial organization and in remote for some sites

• GMP and deep knowedge of Data Integrity requirements

• French/English. German/Italian is a plus.


Offer


Working as a consultant for XPE Pharma & Science means that you will be a part of the Adecco group. You will be guided and be followed-up by one of our Talent Managers. While giving the best of yourself at your project you will be able to develop your soft & hard skills as well via our Talent Managers.


Why work as a consultant for XPE Pharma & Science?

• XPE is a part of Adecco, one of the Top 5 companies within the 'Great Place to Work' ranking

• Dynamic colleagues with passion and drive

• The opportunity to develop yourself, your competences and skills within our organization

• An interesting salary with extra-legal benefits. We offer meal vouchers, group- and hospitality insurance.


Information


Andrea Baetens
+32 10 80 71 15


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