CSV Engineer

3 weken geleden

Leiden, Nederland Science at Work Staffing Voltijd
Job description
In this job as Quality System Specialist, you will join a dynamic QA team within a global biopharmaceutical company. In this job you will be responsible for all quality related aspects when it comes to the use of computerized systems. You ensure compliance of all computerized systems (hardware and software) by making sure all these systems are qualified and validated in line with GMP regulations.  
Hereto, you write/review, implement and maintain all QA related documentation for use of computerized systems. 

You will act as a subject matter expert (and trainer) regarding computer system validation and set requirements for the configuration, validation, implementation and maintenance of automated quality systems. Also, you will propose ideas for improvements and contribute to internal and external audits (GMP, but also GLP, ISO, GCP and GDP). 

In short, in this position you are a Quality System Specialist and will contribute to all matters concerning Computerized Systems (CSV). 

Profile
For this job, we are looking for a Quality Professional with the following background:
  • HLO or MSc laboratory degree, for instance (bio)chemistry or biomedical sciences.
  • Several years of QA work experience in a (bio)pharmaceutical company.
  • At least 3 years of experience in qualification and validation of computerized systems (CSV). 
  • You have good knowledge of GMP regulations, specifically the computerized systems related ones (GAMP-5, EU-GMP Annex 11 and US-CFR21 part 11). 
  • You are fluent in English and are able to communicate about quality matters on different levels. 
  • You are quality minded, good in keeping overview and have a proactive approach at work. 
  • You are eligble to work in The Netherlands and are living within an hour commute of Leiden. 

Offer
This is a position within an international biopharmaceutical company. The company is dedicated to improve the lives of patients by development and production of specific therapies. The QA team is a hard working team of enthusiastic people who are willing to help each other. 

Terms & Benefits: 
  • Permanent job, starting with a 12 month contract
  • Competetive salary (€5000 - €6000 depending on experience)
  • Working hours: 32-40 hours/week
  • Flexibility to maintain a good work-life balance 
  • Excellent benefits (including 30+ paid vacation days, holiday allowance and a good pension)

Over Science@Work

Bij Science@Work komen mensen en wetenschap samen. Onze Talent Acquisition Experts zijn allen een gesprekpartner op niveau met een afgeronde laboratorium en science opleiding. Wij brengen talent en werkgevers samen voor vaste – en tijdelijke banen in geheel Nederland. Als gespecialiseerde divisie van de internationale recruitment groep Pauwels Consulting, met 1500 professionals in dienst, 20 kantoren in Nederland, België, Frankrijk, Duitsland en Zwitserland, hebben wij een groot bereik en nog grotere branche kennis. Science@Work staat gelijk aan kwaliteit en kennis. Waarin Science@Work zich verder onderscheidt zijn de nieuwste recruitment technologieën, bevlogen recruiters en aandacht voor mens en milieu. Zo werken wij sneller, efficiënter én groener. Science@Work werkt voor MLO, HLO en WO professionals in de life sciences, farmacie, voedingsmiddelen, biotechnologie en (petro)chemie in geheel Nederland. Wij bieden vaste en tijdelijke laboratorium en science banen binnen de microbiologie, chemie, analytische chemie, biochemie, sales, quality assurance, medical devices en biomedische laboratorium technologie. SAWNL

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