freelance
CSV Consultant Reference number: 1124
Last update: 12-12-2019, 13:36
Region: Wavre
Sector: Pharmaceutical
ASAP - until December 2022
Job description
Purpose of the Mission (project & department description)

As part of the Data Integrity remediation project, a person responsible for the QA CSV role dedicated to the project should be set up.
The mission consists in carrying out a Quality Oversight of the CSV validation activities during the different phases of the project.
What you’ll do
  • Quality Oversight of CSV validation activities during the different phases of the Data Integrity remediation project.
  • Define validation strategies in accordance with GMP requirements and local SOPs and write the valdaiiton plan.
  • Review and approve all project documentation: TCD, ERES, IQOQ protocols and reports, PQ protocols and reports,...
  • Write the Validation Summary Report.
  • Actively participate in project monitoring meetings in order to anticipate impacts or risks, validations and propose solutions.
  • Report problems blocking the QA CSV manager.
Profile
  • CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …)
  • Validation practices and guidelines (life cycle approach, ICH, ASTM E2500, …)
  • Technical knowledge of automated and computerized systems
  • Bachelor or Master degree in automation, engineering, IT, sciences or equivalent by experience
  • ICT Skills (software, operating systems, hardware, etc.)
  • Office 365
  • English, French
  • Autonomous, Critical mind, Team spirit, Leadership skills
Interested? Send us your resumé
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Thank you for your interest in working with Harvey Nash and we look forward to assisting you in your job search!

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Only PDF, max. 10MB