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Offre d'emploi: CSV COMPLIANCE ANALYST Heist-op-den-Berg:SelectHR

Job description:


Référence: ANT060612019036


For one of our pharma clients in Heist-op-den-Bergwe're looking for a COMPUTER SYSTEM VALIDATION (CSV) & IT COMPLIANCE ANALYST (M/F).
As part of our client's transit program, to lead the sub-project for the new WERUM MES Core Weigh & Dispense solution to be used in OSD Central Weighing and the Sterile Department. This includes the replacement of the existing scales and controllers and all of the required Equipment Qualification activities. This project will also include some Computer Systems Validation (CSV) work that needs to be completed in compliance with the company SDLC (System Development Life Cycle).
In addition, you will also provide support to the Quality Management System (QMS) Chapter 14 (?Computerized Systems?) sub-system owners. The work within this compliance area includes, but is not limited to, the following:
   » Management and completion of CAPA's (Correct Actions & Preventive Actions)
   » Management of Deviations, i.e. NOE's (Notification of Events)
   » Support for Periodic Review completion
   » Support for Data Integrity
   » Support for SOP (Standard Operating Procedure) changes
   » Support for any observations deriving from Internal or External Audits or Inspections
   » Support for deployment of SDLC changes
   » Support for QSIP changes as they apply to the current QMS Chapter 14

Le profil

   » You have a degree in a technical or scientific discipline.
   » You have pharmaceutical GxP expertise and practice (>3y)
   » You have Computer System Validation practice (>3y)
   » You can work independently and in team;
   » You are fluent in Dutch and have a good expertise of English .
   » You possess expertise of the GAMP (Good Automated Manufacturing Practices) Industry Standard
   » expertise of IT (Information Technology) would be beneficial but not mandatory

Nous offrons

You will receive an attractive income package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop.


Select Projects is part of an international full-service Human Resources organization: Select HR. Select Projects specializes in offering solutions through projectsourcing. From our offices in Belgium, the Netherlandsand Dubai, we provide support to companies who need practiced specialists / project staff in several areas. We distinguish ourselves by our good follow-up and service to all our customers and our employees.

Contrat Type:
Groupe de fonctions:
Ingénieur / Technique
Employé AQ
Industrie pharmaceutique

Bureau d'Anvers

Klipperstraat 15

Marlies Collart

T  03 203 50 80


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Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Ander
Company Type Employer
Post Date: 06/13/2018 / Viewed 5 times
Contact Information
Company: SelectHR
Contact Email:

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