Job Title: CSV Data Validation Specialist
We are seeking a highly skilled CSV data validation specialist to join our team in Cork. This role will involve the validation of lab systems in QCL Labs and Manufacturing Operations.
The CSV data validation specialist will be responsible for managing lab equipment validation projects from software installation to business release, prioritizing activities according to project schedules and monitoring progress.
* Develop and maintain computer system validation documentation, including design specifications, configuration specifications, testing protocols, security plans, and test summary reports, in accordance with site procedures and GMP guidelines.
To succeed in this role, you will need a minimum of 3 years' experience supporting and validating lab equipment, updating documentation, system testing, and troubleshooting.
* Experience analyzing and challenging software to identify gaps and areas for improvement.
* Demonstrated knowledge of 21 CFR Part 11 requirements, ER/ES, and data integrity guidelines.
* Excellent communication skills, with the ability to communicate complex technical information to both technical and non-technical stakeholders.
We offer a range of benefits and opportunities for professional development, including education and training programs, compensation packages, and wellness initiatives that support your overall well-being.