Validation Engineer CSV

Science
2440 Geel
Project Sourcing of Freelance
Nederlands
Master
40 h/semaine
Postuler Sauvegarder

Description de fonction

  • Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities. Develops, implements and executes validation studies for cGMP-critical computerized systems to demonstrate compliance to cGMP-, User- and Regulatory requirements
  • Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerized systems
  • Responsible for the validation documentation through approval and implementation
  • Performs validation of systems for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP , cGLP’s and Sanofi Procedures
  • Ensures that the Validated Status of computerized systems is in compliance with cGMP at all times
  • Ensures projects are managed in conjunction with all required Sanofi and cGMP regulatory standards
  • Keeps current on emerging validation regulations and validation testing practices in order to meet or exceed cGMP requirements. Provides technical assistance on current US FDA and EU validation requirements
  • Provides input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate
  • Investigates/troubleshoots validation issues

Profil

We are looking for a validation engineer who has project experience with validation of software packages and computerized systems has: 

  • Strong communication skills
  • The capability of working independently and learns fast 
  • The ability to execute project to plan
  • A good knowledge of Computer Systems Validation
  • A full understanding of relevant quality and compliance regulations
  • The capacities of troubleshooting validation issues
  • Minimum a few years experience working in a pharmaceutical sector and GMP environment
  • A very good knowledge of English and Dutch

Knowledge or experience with DCS systems (Emerson DeltaV) is strong advantage 

Offre

  • A permanent contract with a competitive salary, complemented by a monthly fixed expense allowance, a company car and fuel card or a monthly gross bonus. Additional benefits include €8 meal vouchers, group and hospitalization insurance, a mobile phone subscription, and a year-end bonus.
  • This package is further enhanced with access to Benefits at Work, sport & culture vouchers, and eco vouchers.
  • You’ll also benefit from a varied and dynamic training offering, including both job-specific and cross-functional courses
  • Expect regular feedback and check-ins with your dedicated HR Business Partner
  • Get to know your fellow consultants during our networking events and team-building activities
  • Kickstart your career at USG Professionals with our two-day Bootcamp

Offer as a freelancer: 

  • Streamline your freelance career with the USG EASY app
  • Receive personalized project proposals based on your profile and availability
  • Enjoy transparent follow-up of your invoicing process
  • Manage all your administration in one app

Information

USG Professionals connects the expertise and ambitions of highly educated professionals with the challenges of clients across six different fields: Engineering & Science, ICT, HR, Legal and Finance. We support our clients with temporary needs through project sourcing and with the permanent filling of open positions through recruitment & selection.

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Postuler Sauvegarder