Role Purpose
To lead and execute validation activities for medical devices, ensuring full compliance with applicable regulatory standards and quality system requirements.
Key Responsibilities
1. Manage and execute process and software validation activities in a regulated medical device environment.
2. Serve as the primary point of contact for all validation execution activities on-site in Fermoy.
3. Investigate and resolve validation-related issues effectively and efficiently.
4. Standardize validation and qualification practices across all projects and systems.
5. Provide technical direction and support for the development, execution, and review of validation protocols and documentation.
6. Maintain up-to-date knowledge of current GMP and regulatory requirements to support compliance across the site.
7. Oversee the validation lifecycle, including scheduling and conducting Periodic Reviews .
8. Support change control processes related to process and facility modifications.
Quality Responsibilities
9. Ensure validation practices meet internal quality standards and external regulatory requirements.
10. Assist in audits and inspections, providing validation documentation and expertise.
Health & Safety
11. Adhere to all relevant Health & Safety regulations, ensuring safe execution of validation activities.
Performance Indicators
12. Timely, accurate completion of validation tasks and documentation.
13. Demonstrated compliance with applicable regulatory and quality standards.
Qualifications & Experience
Required:
14. Level 7 qualification (QQI) in Science, Electronics, Mechanical, or Industrial Engineering.
15. Minimum of 2 years' experience in Quality Assurance or Regulatory Affairs.
16. Practical experience in conducting Process Validations aligned with CDRH Guidance .
17. Proficiency in GAMP 4/5 software validation methodologies.
18. Strong problem-solving and analytical skills.
19. Skilled in Microsoft Word, Excel, and PowerPoint .
20. Ability to draft SOPs, training materials, and regulatory submissions.
21. Experience with statistical tools, Design of Experiments (DOE), and DMAIC .
Preferred:
22. Experience in a regulated Medical Device Manufacturing environment.
23. Fluency in German.
24. Certified Six Sigma Green Belt or Black Belt .
25. Knowledge of electronic manufacturing processes .
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