SIRE Life Sciences® is a recruitment and executive search consultancy, dedicated exclusively to the European Life Science industry. SIRE Life Sciences® provides a Complete Life Science Cycle Search Solution to both Life Science Professionals and Life Science Employers operating in the European Life Science Sector. We provide a tailor made European wide service for both permanent and freelance solutions, specialized in delivering to the world's leading Life Science institutions.
Our client is a professional Pharmaceutical organization, based in Noord-Brabant Netherlands.
For a large serialisation project they are currently looking for a freelance IT specialist.
For an update of the IT Systems within the production environment and an upcoming FDA audit, our client is looking for an experienced IT Freelancer for a project of 12 months. In this role you will be responsible for the update of several Management Systems and compliancy to the FDA regulations for the upcoming audit.
Update of the current MES / PCS systems
Compliancy to FDA regulations
Preparation for FDA audits
Data Integrity and Serialisation processes
Merger of several Management Systems
Structuring of the newly developed IT system
BSc. in Life Sciences, Information Technology or similar
Extensive experience with IT in the life sciences industry
Specialist knowledge of MES, PCS and/or LIMS
Previous experience in the Biotech or Pharmaceutical industry
Knowledge of FDA regulations and compliancy
Knowledge of production processes in the bio-pharmaceutical industry
Previous experience in preparation of audits
Serialisation / traceability and Data Integrity knowledge
Fluency in Dutch and English
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