Computerized System Validation (CSV) Consultant

  • Randstad
  • 3500.00 - 5000.00
  • 32-40 uren
  • HBO

Opdrachtgever

Our client is active in the food, life sciences, infrastructure, oil and gas and (petro) chemical markets by delivering:

  • Support through consulting & engineering;
  • delivering turnkey automated solutions;
  • maintenance and support.

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Opdrachtgever

Our client is active in the food, life sciences, infrastructure, oil and gas and (petro) chemical markets by delivering:

  • Support through consulting & engineering;
  • delivering turnkey automated solutions;
  • maintenance and support.

functie Vereisten

  • You preferably have at least a master or engineer’s degree in a technical or scientific field, linked to life sciences.
  • You have 5 years of experience with computer validation in a GMP environment and you know how to use some of its associated applications (ex.: MES, ERP, LIMS, EBR, QMS/eDMS, etc.).
  • You have broad/general knowledge on computerized systems and automation (ex.: data security, data exchange, infrastructure, PLC, SCADA, MES-systems, ERP, etc).
  • You are familiar with working according GAMP 5, and aware of current insights regarding 21 CFR-part11.
  • You are able to work precisely and accurately and in accordance to specific guidelines and rules (ex. GMP, GLP).
  • You have good communication skills at different (social) levels.
  • You are self-reliant and organized, with a team spirit.
  • You have experience with MS Office.
  • You express yourself fluently in English, oral and written. Dutch is a big plus.

Wat krijg je?

  • Pension entitlement as from day one
  • Collective WGA / WIA insurance
  • NBBU / ABU collective labor agreement
  • 25 holidays days
  • 8,33% holiday allowance
  • 100% payment in case of illness after one waiting day
  • Travel allowance

Werkzaamheden

To strengthen the validation team of our client, we are looking for an experienced CSV Consultant. You will monitor the quality of processes, systems, equipment and/or software applications, used for research and production of medicines.

Description
  • You develop the validation strategy and carry out validation activities on an R&D site or a production plant.
  • You prepare ‘high level’ documents (validation master plans, criticality analysis), protocols and scripts, procedures and reports, up to the final delivery.
  • You may be conducted to supervise a team of validation engineers in the execution of validation activities.
  • You strictly work according procedures and guidelines.
  • You report on the progress of these validation activities to the project manager.

TAGCLOUD

Sander Pupella

Geïnteresseerd?

Stuur uw cv naar sander@tailorminds.com onder vermelding van vacature id (847)

Meer informatie?

Neem contact op met Sander Pupella van ons kantoor te Zoetermeer, te bereiken op nummer +31 6-13140754

SOLLICITEER MET ONDERSTAAND FORMULIER

CQV & Compliance
Automation
Mechanical & Process
Project Management & Engineering

CQV & Compliance

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