JUNIOR MANAGER STABILITY TESTING

7 jours restants

Région
BORNEM
Publication
mardi 4 avril 2017
Date limite
jeudi 4 mai 2017
Réf
6A6D6XPE-BE
Contact
Julie Begine
Fonction
Autre
Niveau d'expérience
0 à 2 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: JUNIOR MANAGER STABILITY TESTING 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.

Job description:

Managing of stability studies to demonstrate that the quality of the products is kept until their end of shelf life. Giving Lead to analysts performing analyses for stability, process validations and method development. Reviewing and approving stability protocols and analysis methods. Verifying the correct entry of the stability tests and the frequency plan in the stability database. Verifying the correct entry of results in the stability reports and check if there are no negative trends. Discussing negative results and trends with the RA and QA department. Controlling raw data in case of OOS results and making sure that the correct results are recorded. Writing annually stability reports of the human medicines. Planning of the analysis work in collaboration with the Analytical Development Specialist. Writing SOPs and ensuring that they are up-to-date. Responsible for the managing of the stability rooms in collaboration with the calibration responsible. Reviewing and approving the analytical part of the process validation protocols and reports. Planning of the analytical testing of process validation. Keeping up-to-date with the current guidelines regarding stability testing. Back-up of the Analytical Development Specialist regarding method development and validation. If the operation of the department or organization as such requires it, temporary additional tasks can be imposed.

Profile:

You are knowledge of GLP, expertise in analytical methods, laboratory Safety, current guidelines on stability testing and of course you speak Dutch and English fluently.

Offer:

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.



Licenses
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