Computer System Validator
Vor 6 Tagen
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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