Process Control Validation Coordinator

6 jours restants

Région
Wavre
Publication
mardi 30 mai 2017
Date limite
vendredi 30 juin 2017
Réf
6D56AXPE-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: Process Control Validation Coordinator 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:

In the context of investments (new or upgrades) or alignment projects in Vaccine R&D, ensure proper execution of the R&D validation methodology and application of cGMP (Validation Master Plan, URS, RA, Design Qualification, Installation & Operational Qualification, Performance Qualification and Validation Reports) and specific regulations applicable to the “computer” domain (such as FDA's 21 CFR Part 11 or Eudralex Annex 11).

Ensure the application of R&D SOPs (such as Change Control, Incidents Management, Access Management, Backup and Restore,…) for the projects he coordinates.

Manage, schedule, coordinate and track each qualification or validation activities to ensure timely completion of the validation plan in coordination with Production, Technical, Quality Control, Quality Assurance and Regulatory departments.

Monitors that validation deviations are properly generated, managed and completed.

Coach the User, Technical Services, Validation and QA regarding the R&D validation methodology applied to automated systems.

Reports significant issues he identified to the Manager he reports to.

Profile:

University level (engineering, automation, IT, biological laboratory equipment…) or equivalent by experience.

  • Bilingual French/English (spoken and written)
  • Knowledge of main laboratory automation and IT principles and components (PLC, SCADA , HMI, network, spread sheets…)
  • Knowledge of process control part of standard automated lab systems, such as :HPLC, Bioreactors / fermentors
  • Knowledge of good practices in electronic records management
  • Knowledge of risk analysis methods applicable to computerized systems (such as FMEA)
  • Good knowledge of projects and qualification steps, including commissioning.
  • Have already demonstrated success in implementing its discipline in minor or major projects.
  • At least three years experience in CSV applied to R&D or QC lab equipment
  • Good skills and competencies level in validation activities : organization, understanding and implementation of validation practices in projects, time schedule, team working,
  • Good expertise in GMP Practices (V cycle, GAMP, Data Integrity)
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