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Cleaning Validation SME

  1. Belgium, Brussels
Brussels
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
36903
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Cleaning Validation SME - Brussels, Belgium - 3/6 Months Contract

We are looking for an experienced Cleaning Validation SME for a fantastic 3-6 months contract based in Brussels.

You will be working with our client who are a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease.

This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.

Responsibilities:
  • Ensure the validation of cleaning processes for equipment involved in manufacturing processes (bioprocess) in compliance with GMP and HSE regulations and in accordance with the Site's Validation Master Plan (VMP).
  • Ensure the ongoing auditability of the files in charge.
  • Conduct/Lead quality risk analyses
  • Define the validation strategy in agreement with the project team
  • Draft the validation plan and associated documents
  • Coordinate executions
  • Draft reports and conclusions
  • Develop a partnership with internal clients, internal support services (IT, Metrology, Periodic Inspection), and external suppliers.
  • Work in collaboration with the Quality Assurance Department to ensure compliance with applicable regulations, guidelines, standards, and internal procedures (SOPs).
  • Participate in internal audits, external audits, and regulatory inspections (national and international authorities, FDA, EMEA, etc.). Report to managing any issues impacting the quality of systems, instruments, or products manufactured and/or under development.
  • Make appropriate decisions regarding deviations impacting the qualification/validation strategy.
  • Ensure compliance with applicable legislation and HSE regulations.
Requirements:
  • Degree in a relevant Engineering Field
  • Extensive experience in s similar role
  • Experience of large CAPEX project
If this role is of interest to you, please apply now!

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