Nos offres d'emploi

V.I.E CONTRACT - Computer System Validation Engineer (M-F)


Belgique

CVO/BE/ING/1058

EFOR-CVO is EFOR Group’s Life Sciences brand, a result of two major consulting actors brought together at the end of 2020: Efor Healthcare and CVO-EUROPE. We have decided to join forces to assist medical device manufacturers and pharmaceutical, cosmetic and biotechnology industries, in order to become the leader in the Life Sciences consulting sector.
Our group of over 1300 experts seeks to become the market leader by providing a unique approach to consulting across the full product development cycle of our clients’ business and products and who are subjected to stringent regulatory demands.
Together with the same international aspiration, we gather unique, committed and passionate women and men, working towards our clients’ performance.
Join us now !

To support our development, we are looking for :

V.I.E CONTRACT - Computer System Validation Engineer (M-F)

Permanent contract

Responsibilities
Contract : VIE (Volontariat International en Entreprise)
Localisation : Belgium
Duration : 12 to 24 months
You can start : as soon as possible


DESCRIPTION

He/ She implements the Computerized System Validation (CSV) process and provide CSV support to the R&D department of our client. The VSME Ensure compliance of Computerized Systems in R&D.

He/ She schedules, coordinates and tracks each qualification or validation activities to ensure timely completion of the validation plan in coordination with User, Technical, Quality Control, and Quality Assurance under the accountability of the Validation Owner (VO).

The consultant has enough experience and technical expertise to realize autonomously and properly all CSV activities and documentation. This task should be managed with rigor, effectiveness and compliantly with regulation and standards of the Service center.

Thanks to his/her initial training and experience He/She Shall have a minimum of understanding in the technical field of expertise (Laboratory QC, R&D processes, procedures, equipment, systems, laboratories, IT, automation ...:)

He/She should be able to:
Apply the strategy determined by the VO.
Leads project coordination between different teams
Find, read, and understand the GXP regulation, specific pharmacopeias, norms and standards applicable.
Read and understand input project documentation of CSV such as: URS/URB, compliance determination, Functional specifications, technical specifications, ?
Create/edit, review validation deliverables under VSME scope (Deliverables following the validation procedure 9000044709 (CD,VP,URS, RA, DRP, TM,IOQ protocol and report, PQ protocol and report, PR protocol and report, Decommissioning protocol and report, Migration protocol and report, UG, NC, VR)
Execute tests :dry-run and Validation IOQ tests
Create/edit, review non-conformities
Create and update specific documentation QC, QI,QO,QP),
Prepare, execute and document IOQ tests ( in Complia

Qualifications/Skills
Theoretical knowledge
• Master the art of CSV.
• Master Data integrity principles.
• Master the Regulatory and norms for his/her speciality.
• Master Ms Office Tool.
• Master GxP Manager tools.

Know-how
• Able to speak in public.
• Excellent Writing skill in French (Good in English).
• Capacity to explain defined validation strategy.
• Capacity to work in team.
• Capacity to integrate and communicate with Clients.
• Outstanding rigor from a documentation standpoint and data integrity of data issued during the testing.

OUR OFFER

• An international Leader Company in the Engineering, Validation and Quality sector, which offers you interesting project.
• A strong corporate culture ensuring a personal and professional blooming and self-fulfillment.
• Overall trainings and a personal career management.
• A good salary package with a lot of extra legal advantages.

Interrested ? Don’t hesite to send your CV via stephanie.vogne@cvo-europe.com

publication date : 29/11/2021

  1. Mrs Mr



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