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Brunel

Support in Computer System Validation & IT Compliance Activities

VC439865 SVDL

Via Brunel

Published on Jobat.be 6 days ago

This project for one of our clients 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 work that needs to be completed in compliance with the SDLC (System Development Life Cycle). 

Support in Computer System Validation & IT Compliance Activities

Job description

The work within this compliance area includes, but is not limited to, the following: 

  • Management and completion of CAPAs (Correct Actions & Preventive Actions) 
  • Management of Deviations (i.e. NOEs [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

Profile

  • Native Dutch speaking and fluent in English 
  • Experience working within the Pharmaceutical Industry (more than 3 years) 
  • Good understanding of Good Manufacturing Practices (GMP) 
  • Experience with Computer System Validation (CSV) (more than 3 years) 
  • Knowledge of the GAMP (Good Automated Manufacturing Practices) Industry Standard 
  • Knowledge of IT (Information Technology) would be beneficial but not mandatory

Offer

We are always looking for new talents who fit in our Brunel team and who match with our clients need for specialized support. 

We offer an interesting salary package and job opportunities in dynamic high-tech life sciences environments. 

Become a member of our Brunel Crew and we will help you fulfill your career ambitions.

Mechelen - Lier

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Brunel

Blarenberglaan 3, 2800 Mechelen

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54 days left to apply

Characteristics

Requirements

  • Academic Bachelor
  • At least 2 years experience
  • Dutch, English

Offer

  • Permanent
  • Full-time

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