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Quality CSV Consultant

Role Test Engineer
Technology Quality

Profile
Ordina, specialized in IT related validation, is seeking for experienced Validation Consultant for challenging projects within the pharmaceutical domain.

As a Validation Consultant CSV, you will support our customers in Pharma in setting up and maintaining IT solutions and services falling under regulatory requirements. As a part of a project team on the customer side, with support of technical solution experts and developers, you prepare, execute, and finalize the validation of computer systems to be used in the production or development of pharmaceutical products. You are a competent partner for our customers in questions around computer system validation.

You are responsible for the execution of validation activities such as validation planning, preparing user specifications and IQ-OQ-and PQ documentation, SOP’s, …

You are able to complete training materials and provide training on topics that are in your area of expertise.


Function Requirements
  • At least 3 years experience in CSV validation and a sound knowledge of one of following domains:  21 CFR Part 11, GxP, SOX, FDA, …
  • Graduated with Bachelor or Master degree
  • You have excellent communication skills
  • You are analytical, can set priorities and have the sense of planning and organization
  • You have a strong interest in IT environment
  • Client oriented
   
What Ordina offers
  • Challenging projects within a versatile circle of customers
  • An open no-nonsense company culture with room for personal initiative
  • A high tech environment with focus on knowledge and innovation
  • A great number of workshops, trainings and events in cooperation with Ordina Academy of the Ordina Education Centre
  • Real possibilities to grow within the company and to clearly define your career on the basis of an Human Talent Management Program
  • Regular team events and social company events
  • An attractive salary in accordance to the market situation with a wide remuneration package such as a company car, laptop…
   
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