Sr Manager Software Validation

Monterrey Permanente MXN100,000 - MXN130,000
  • Build and maintain the Computer System Validation and compliance program
  • English Advanced

Sobre nuestro cliente

Internactional Manufacturing Company looking for Sr Manager Software Validation


Main responsibilities are:

  • Experience shall include validation of Computer Systems, investigations, and change control in a medical device manufacturing environment.
  • Work with Enterprise Architecture and IT Platform leads in both Functional IT
  • Knowledge of FDA 21CFR Part 11/820, ISO13485 and other applicable regulations.
  • Experience at writing/executing validation plans, IQ, OQ and PQ qualification protocols and reports for computer systems
  • Develop and manage a high performance team of computer system validation analyst.

Perfil buscado (Hombre / Mujer)

10 years+ of computer validation experience in the medical device manufacturing industry or equivalent. English Advanced. Bachelor's degree in sciences, engineering or IT. Strong knowledge in Medical Device industry: FDA, 21CFR...

Qué Ofrecemos

Base Salary + Benifits

Christophe Lustiere
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Christophe Lustiere
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