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Validation Specialist

Our client offers a dynamic range of fully integrated services to meet the complex clinical supply challenges pharmaceutical and biotechnology companies are facing.

The company combines market-leading clinical trial services like comparator sourcing, packaging and labelling with biological sample management. The company delivers tailored solutions for clients to ensure their clinical trials are a success, regardless of size or scope, from Phase I to Phase IV projects

What is your job?

In the framework of the compliance project, the QA validation senior specialist will:

– Put in place an active SVMP and keep it live and up to date

– Ensure the stability of the validation system, sops and templates to lead to performance

– Meet the ever-increasing validation requirements of audits and inspectors

– Use risk-based approaches to make validation activities efficient, cost-effective and defendable

– Take the lead for validation activities from a Quality Perspective

– Analyse and improve the site validation master plan

– Adopt a Risk-based approach to validation activities 

Who is the candidate we are looking for?

  • Experience in Quality Assurance (5 years)
  • Experienced in wide range of validation activities-facility qualification, equipment qualification, process validation, cleaning validation/ verification
  • Experience in data integrity and computer system validation
  • Experienced in GMP, GDP, and GCP requirements
  • Experience in working in a matrix organization
  • Excellent communication and intercultural skills
  • Team worker and team spirit
  • Customer oriented
  • High organizational and planning skills
  • Work with accuracy and reliability
  • Good dose of assertiveness
  • Fluent in French and English (any additional language is an asset)

Want to take this challenge?

Send your resume to roxane@nuwhi.be or to liske@nuwhi.be and tell us a little more about yourself. We will hear from you soon!