Freelance CSV Qualification of Equipment (REF9332X)

  • Schipholweg, Leiden, Netherlands
  • Contract

Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

Job Description

This is a 2 months freelance full-time project requiring onsite presence.

Computer Systems Validation Consultant is responsible for independently managing Computer System Validation-related projects and qualifications of Packaging/Label printer equipment. It will provide basic support to computer system validation activities focusing primarily on verification test execution, limited technical writing, and quality assurance tasks.

The role will also include execution of IQ qualification.

Qualifications

  • Bachelor’s or Master’s degree.
  • Experience in different areas of business including manufacturing, warehousing, distribution, and validation departments.
  • Experience in writing and executing of IQ, OQ Protocols according to GDP, GAMP ruling, and guidances
  • IT-related technical knowledge and demonstrated expertise.
  • Fluent in Dutch and English and preferably at least one other European language.
  • Knowledge and understanding of developments in various disciplines in the Pharmaceutical industry and (cross-functional) consultancy services.
  • Ability to implement action plans to solve complex scientific problems.
  • Cross-cultural understanding and working experience across different countries.
  • Experience with GxP compliance and validation in the life sciences sector.
  • Excellent experience with validation of computerized systems.
  • Client-oriented, dedicated, flexible, proven project management skills with helicopter view and able to quickly switch between different assignments.

Additional Information

All candidates must be legally eligible to work in The Netherlands.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

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