Computer System Validator

Vor 6 Tagen


Bern, Bern, Schweiz Capgemini Vollzeit

As a Computer System Validator at Capgemini Engineering, you will be responsible for assessing and producing high-quality computer system validation packages on assigned projects.

Responsibilities
  • Develop and execute validation plans, risk assessments, and test scripts to ensure compliance with regulatory requirements.
  • Review and approve technical documentation, such as user requirements specifications and qualification/validation reports.
  • Collaborate with cross-functional teams to understand customer needs and define electronic records requirements for computerized systems.
  • Contribute to the development of quality assurance processes and procedures.

You will have the opportunity to work in a dynamic environment and grow professionally and personally.

Your Profile

  • Bachelor's or Master's degree in a technical or natural science field.
  • Minimum 4 years of experience in computer system validation and quality assurance.
  • Knowledge of FDA 21CFR part 11/EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines.
  • Strong analytical and problem-solving skills.


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