Sterilisation Expert 6239

1 jour restant

Région
Wavre
Publication
lundi 24 juillet 2017
Date limite
jeudi 24 août 2017
Réf
7798AXPE-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: Sterilisation Expert 6239 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. Provides support and expertise to the operations to ensure that the Manufacturing Performance Unit applies Sterility Assurance processes (a.e. Aseptic Practices, Environmental Monitoring, Cleaning and Sanitization, Sterilisation, Media Fill) to confidently deliver products to patients with the highest sterility assurance level at an appropriate cost. Establishment of new sterilization techniques for the asceptic center.

Job description:

Ensure industry practices of quality management related to aseptic are in place and in use. Manage relationship with aseptic operation. Identify potential quality and compliance risks and help to manage these risks through the existing quality systems. Performs gap analysis, system effecttivness reviews and other management reviews, as required. Assures the adequate facilities contamination control practices monitoring tools are provided to Production to guarantee the best environmental monitoring indicators levels. Guarantees the maintenance of the cGMPs in the area of responsibility (SOP, documentation, audits, training, method validation). Ensures and supports the implementation of adequate training and practices related to sterility assurance, including shop floor mentoring as required. Contributes to inter-MPU QA meetings to share knowledge and practices and to review sterility assurance issues as to foster continuous improvement and manage risks. Participation in process improvement projects : Moist heat sterilization (autoclaving), Work in sterilization rooms, Helping for the Deployment of working tools, Assists in the evaluation of aseptic processes through tool developed by the Department, Search for solutions to improve the sterile area activities, Participate in certain investigations in case of problems on aseptic manufacturing process, Monitoring validation activities irradiated filters instead of autoclaved filters, Identification and monitoring implementation of alternative solutions to the use of the autoclave, Responsible for documentation related to change control, Operational follow-up on site to ensur informing operators on good and bad practice.

Profile:

Relevant experience in aseptic operations (min. 3 to 5 years) Previous experience in QA in the pharmaceutical industry Experience in GxP Previous experience in GSK is a strong asset Sterilization process including preparation of materials to be sterilized Aseptic Process Lean and 6 Sigma tools Hands-on approach Able to work on the shop floor with a coaching and mentoring style to impact individual experiences Strong communication skills with all levels Influencing skills Builds trust and rapport with others Flexible mindset Knowledge sharing Achievement oriented Team player Change management Technique and process oriented PhD or Master in Sciences (Microbiology, Engineering, Bio- engineering, , Pharmacy ……) or equivalent by experience Significant GxP experience SAP, Excel, Word MS Office English & French

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. XPE is a part of the Adecco group, one of the top 5 companies for 'Best Place To Work'.



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