Role Purpose
To lead and execute validation activities for medical devices, ensuring full compliance with applicable regulatory standards and quality system requirements.
Key Responsibilities
* Manage and execute process and software validation activities in a regulated medical device environment.
* Serve as the primary point of contact for all validation execution activities on-site in Fermoy.
* Investigate and resolve validation-related issues effectively and efficiently.
* Standardize validation and qualification practices across all projects and systems.
* Provide technical direction and support for the development, execution, and review of validation protocols and documentation.
* Maintain up-to-date knowledge of current GMP and regulatory requirements to support compliance across the site.
* Oversee the validation lifecycle, including scheduling and conducting Periodic Reviews.
* Support change control processes related to process and facility modifications.
Quality Responsibilities
* Ensure validation practices meet internal quality standards and external regulatory requirements.
* Assist in audits and inspections, providing validation documentation and expertise.
Health & Safety
* Adhere to all relevant Health & Safety regulations, ensuring safe execution of validation activities.
Performance Indicators
* Timely, accurate completion of validation tasks and documentation.
* Demonstrated compliance with applicable regulatory and quality standards.
Qualifications & Experience
Required:
* Level 7 qualification (QQI) in Science, Electronics, Mechanical, or Industrial Engineering.
* Minimum of 2 years’ experience in Quality Assurance or Regulatory Affairs.
* Practical experience in conducting Process Validations aligned with CDRH Guidance.
* Proficiency in GAMP 4/5 software validation methodologies.
* Strong problem-solving and analytical skills.
* Skilled in Microsoft Word, Excel, and PowerPoint.
* Ability to draft SOPs, training materials, and regulatory submissions.
* Experience with statistical tools, Design of Experiments (DOE), and DMAIC.
Preferred:
* Experience in a regulated Medical Device Manufacturing environment.
* Fluency in German.
* Certified Six Sigma Green Belt or Black Belt.
* Knowledge of electronic manufacturing processes.
#LI-KO4
Skills:
Validation quality regulatory
#J-18808-Ljbffr