
Data Validation Specialist
2 weeks ago
We are seeking an experienced Data Validation Specialist to join our team in Dublin, Ireland.
About the RoleThe ideal candidate will be responsible for developing and executing validation plans, protocols (IQ/OQ/PQ), and reports for laboratory instruments and computer systems. This role requires a strong understanding of regulatory requirements and industry standards.
- Develop and execute validation plans, protocols (IQ/OQ/PQ), and reports for laboratory instruments and computer systems.
- Perform risk assessments and impact analyses to determine the validation requirements for new and existing systems.
- Ensure compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP 5).
- Collaborate with cross-functional teams to ensure successful validation and qualification activities.
- Maintain and update validation documentation, including validation master plans, standard operating procedures (SOPs), and validation summary reports.
In this role, you will work closely with our cross-functional teams to ensure the successful validation and qualification of our laboratory instruments and computer systems. You will also maintain and update validation documentation to ensure compliance with regulatory requirements and industry standards.
Requirements- Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field.
- Extensive experience in computer system validation and laboratory instrument qualification.
- Strong knowledge of regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11) and industry standards (e.g., GAMP 5).
- Excellent documentation and technical writing skills.
- Strong analytical and problem-solving abilities.
- Ability to work independently and as part of a team.
- Excellent communication and interpersonal skills.
This is an excellent opportunity for a skilled Data Validation Specialist to contribute to the development of our large-scale facility.
What We OfferWe offer a competitive compensation package, opportunities for professional growth and development, and a collaborative work environment.
How to ApplyIf you have the necessary skills and experience, we encourage you to apply.
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