CSV Specialist

  • Location: Wavre
  • Type: Contracting
  • Job #16582

CSV Specialist

Brabant Walloon – contracting

Our partner is looking for a CSV Specialist to join its team. This international company is well-known for its pharmaceuticals.

Your responsibilities?

  • Responsible for CSV activities:
    • Support the inventory of Excel template used for QA release purposes
    • Creation and follow-up of Technical Change Description – i.e. Change control mgt
    • Creation of IQOQ protocols
    • Execution of IQOQ protocols
    • Creation of IQOQ reports
    • Manage set-up in conformity for any template that needs validation, by setting in place new system/new template if needed (update of procedures, communication/training related to new system to be applied to be compliant to validation rules)
    • Manage any deviations or non-conformity according to internal procedures
    • Lead discussion with all stakeholders (QA/Validation/QA release shopfloor) in relation with CSV validations
    • Manage documents related to validation in Techshare (from draft to approval)
  • Manage the digitalisation and transformation for GMP Documentation and Training package/records
    • Create videos through Quick capture, Camtasia, Powerpoint or any other tool for pedagogic training package
  • Participate actively to process improvement initiatives and support internal audit activities when applicable
  • Participate to ongoing investigations related to validation of any microsoft office template/digitalisation and ensure CAPA follow-up when applicable
  • Take an active role in the review of procedures linked to the activity (WKIs, LSOP)

Your profile? 

  • Pharmaceutical Sciences, Biology, Chemistry, Bio/Chemical Engineering or any other applicable scientific discipline
  • Minimum 3 to 5 years’ experience in a computer systems validation role 
  • Have already demonstrated success in computerized system validation (Excel is a plus), quality operations and project management
  • Good knowledge of cGMP (data integrity aspect is key)
  • Experience in a operational role (Production, Validation, etc) is usefull to understand shopfloor issues and discussions.
  • Good knowledge of Microsoft Excel: design, functions, macro and VBA.
  • Good knowledge of Validation/Qualification process and good knowledge of quality systems (deviations, change control, …)
  • Good knowledge of Microsoft Powerpoint (animations set up), of any videomaker software (Camtasia, QuickCapture) and of any software for documentation/data digitalisation is a plus
  • Effective and influential communicator
  • Fluent in French & English, excellent level of written English

Our offer?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Anaïs Malikian, [email protected]  

Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.

We are uploading your application. It may take a few moments to read your resume. Please wait!