QA CSV Engineer

NL1524

DPS Group Global is currently seeking for a QA CSV Engineer.

Category:
Automation
Location:
Netherlands
Years of Experience Req.:
>3 years
Date Posted:
07/09/2020
Days Remaining:
6
Employment Type:
Contract
Education Level Req.:
Bsc or Msc degree

DPS

DPS is a leading Project Management and Engineering Company serving industry around the world for 40 years. Our reputation is based on forming successful partnerships with our clients, providing them with innovative designs and cost effective solutions in the context of sound judgment, strong management and technical excellence.
We provide Full Service Engineering for our clients including Project and Programme Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification and Start-up on numerous projects across a range of market sectors. Our Main market sectors are; Pharmaceutical and Biotechnology, Medical Technologies, Oil & Gas, Advanced Technology, Science & Education, Food & Beverage, and Energy.

 

Responsibilities:

  • The Quality Engineer is responsible for classification of laboratory systems, whether computeriz473373.835725ed; Reviewing and writing qualification documents (URS, protocols / reports, etc.); Close contact with the internal customers; Verification of qualification documents produced by outside companies. Works with moderate work direction and is skilled and knowledgeable to the position.
  • Writing Quality Assurance Plans
  • Drawing up the Requirement Specification together with business SME
  • Setting up and carrying out the User Acceptance testing together with the business SME
  • Writing the Quality Assurance Summary Report
  • Writing Installation document, Configuration specification, documentation index.
  • Other SDLC documentation. such as Tracebility Matrix, Configuration Specificate - support for run and operate processes such as change control and periodic review

 

Qualifications:

  • Experience with Computer system validation of laboratory systems
  • Familiar with pharmaceutical industry
  • Familiar with GxP, 21CFRpart11, GAMP - SDLC processes (System Development Lifecycle)
  • Good communicative skills in English (and preferably Dutch)
  • Familiar with IT configurations of Lab computers

 

Available and interested?

If you’re interested in this role and if you want to be part of growing organisation within engineering projects in the pharma industry or if you would like to discuss this vacancy further and to discuss your career options in confidence, please telephone Ralf Huisman on +31 6 11408791 or send your CV to ralf.huisman@dpsgroupglobal.com

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