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Junior CSV Engineer

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SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

The company

Our client is a professional Biotechnology and Medical Devices organization, based in Antwerpen Belgium. Our client is a professional Medical Devices organization, based in Flandre Orientale Belgium.
Medical Devices company, urgently looking for a Junior Validation Consultant.

Role description

De persoon die we zoeken gaat voornamelijk support moeten geven aan verschillende validatieprojecten onder leiding van onze validatie engineer. Hij of zij zal dus in staat moeten zijn om de technische specten van het project te begrijpen en support moeten leveren in het schrijven/reviewen van validation protocols (IQ/OQ/PQ) en opvolgen dat alle deliverables tijdig worden opgeleverd. Problemen worden ge-escaleerd naar de validation engineer en project lead. Hij/zij zal moeten kunnen werken met verschillende stakeholders zoals contractors, intern IT, operations, etc. Ook opstellen van documentatie voor de goede werking vd nieuwe/veranderde processen en eventueel supporteren in het kwaliteits departement van een ISO 13485 gereguleerd distributie center zal binnen het takenpakket behoren.

Responsibilities

Medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. The EDC is ISO 13485 certified and must therefore follow a thorough validation process for new or modified systems and installations.
The scope and extent of such qualification and/or validation activities (such as storage, pick and pack, temperature monitoring processes) should be determined using a documented risk assessment approach.

Computerized systems including equipment and installations for :
• Product Handling, Storage, Distribution and Installation
• Inspection, Measuring and Test Equipment

The preferred validation model is the V model demonstrated below where CSV means Computerized Systems Validation plus the associated equipment and installations. The V-model is further described in the EDC validation procedure, with more details about each section.
It’s the purpose to include all the tasks of this V model as of the start of this project, from defining the requirements till the final closure of the project.
It’s the intention that the documented validation package is part of the scope that must be delivered. The validation needs to be performed by a qualified person in validation activities.
All validation activities must follow Good Documentation Practices.

GAMP5 – Guide for Validation of Automated Systems

Requirements

Knowledge of ISO 13485
Knowledge of CSV/Validation principles and methodologies
Willingness to learn
Experience in Medical Devices

Immediately available



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SIRE Life Sciences

Ref. number: 32393
Listed by: SIRE Life Sciences
Listed on: 20-07-2017
Country: Belgium
Region: Anvers
Employment: Freelance
Expertise: 0 - 2 years
Location Type: On location
Language: English
Sector: Medical Devices
Specialisation: Quality

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Contact

THE NETHERLANDS

Spiegelhof
Herengracht 466
1017CA Amsterdam
+31 (0) 20 658 9800

BELGIUM

Science 14 Atrium
14b, Rue de la Science
1040 Bruxelles
+32 (0) 2 588 1277

GERMANY

Fünf Höfe
Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

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