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Sr Manager Software Validation
  • Abasolo, NL
  • Indeterminado
  • A convenir

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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.

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...

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