That's XPE. For one of our clients we are looking for: Project Support Organisation description:
XPE Pharma & Science offers a unique combination of providing high qualified Scientific, Technical, Commercial and/or Medical expertise through staffing, consultancy, Project management or Project delivery services.
We have more than 250 XPErts helping out our clients in different phases of the development process of a drug/medical device or product.
As a full service organization XPE Pharma & Science offers those specialized HR & project services to Pharmaceutical, Biotech, Medical devices, Agri-food Industries and the Healthcare & CRO environment.
QC-Paperless program is a quality strategy with the vision to replace paper-based documents supporting analytical testing in QC by electronic notebooks.
The Project support position comprises an array of activities that lead to the successful support of the QC-Paperless program overall and more specifically of e-template workstream. It includes but is not limited to:
- Data collection and analysis, and e-template creation following a process
- Strong support of project in diverse project tasks and assignments
- Rigorous application of scientific/practical QC knowledge and technical training received on the mission
The project support maintains and raises the status of quality in the team and enables the project team to uphold its position as reference quality and to deliver excellent services/products.
The project support actively participates and contributes to team knowledge development and the safeguarding of these know-hows in form of standard procedures or others.Job description:
You perform and support data collection: documents, analysis, master data, equipment, etc and with data comparative analysis of test protocols and data reporting form.
You consolidate and create analytical protocols in Excel format and associated documents.
You harmonize templates for test methods and satellites activities.
You support and perform data check: test flow, master data, method pre-approval, etc. to ensure the integrity of the execution rationale underlying test process flow
You identify potential improvements for template documents and process for analytical tasks.
You provide specialized technical or practical expertise in analytical methods and/or knowledge of software and equipment
You adapt to and integrate potential changes during the life of the project.
You ensure project documentation is produced in a timely manner and is stored and archived in line with the company requirements and the quality oversight of all activities related to the area of responsibility.
You support the Project team with independent contribution as well as being a strong team player and the implementation of the process (transfer of knowledge) to project team or to other teams in the program in their routine procedures, collect and share useful project knowledge.
You manage communication of program/workstream to site and vice versa.Profile:
- Knowledge of GMP regulated environment, QC testing, Pharmacopeia is an advantage
- Excel, other IT skills is a plus (SAP, GLIM), electronic laboratory notebook
- Analytical background, knowledge of QC Physico-chemistry analytical methods (HPLC, Spectro, pH, etc.)
- Knowledge of Biopharmaceuticals production and cGMP regulations and guidelines is an asset
- Experience in writing of SOP and quality checklist
- Affinity for working with procedural documents and aptitude to work by application of process
- Meticulous, proactive, autonomous
- Affinity for electronic documentation solutions
- Highly organized and able to manage multiple tasks
- Excellent presentation and communication skills
- Autonomous and resilient
- Inter-cultural interaction and exchange with program team and stakeholders
- Preferably Scientific university degree (Pharmacist, Biology, Medicine, Engineer or equivalent)
- SAP tool, (desirable) GLIMs/Labware
- Microsoft, focus on Excel, Powerpoint, Visio
- Fluent in English & French (Italian/German an advantage)
What do we offer? Well for this position you will start as a Consultant at XPE Pharma & Science. As a consultant you will get an interesting salary package (contract of unlimited term) and extra-legal advantages!
If you are still interested, don't hesitate to apply…We have 2 working days to present your application with our client.
XPE is a part of the Adecco group, one of the top 5 companies for 'Best Place To Work'.
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713