Validating Systems Specialist

5 days ago

Dublin, Dublin City, Ireland beBeeValidation Full time €90,000 - €105,000

We are looking for a skilled CSV Validator. The ideal candidate will be responsible for validating computer systems and software applications to meet regulatory requirements.

The successful candidate will work closely with IT, Quality Assurance, and Operations teams to ensure compliance with regulatory guidelines and internal policies. They will perform risk assessments, identify critical system functionalities, and create validation documentation.

To succeed in this role, you should have strong knowledge of regulatory guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. You should also have experience in computer system validation within a regulated industry.

Bachelor's degree in Computer Science, Engineering, or a related field is required. Proficiency in creating and executing validation protocols, documenting validation activities, and excellent analytical and problem-solving skills are essential.

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