Job Description:
We are seeking a highly skilled and experienced professional to join our team at {company}, an award-winning Medical Device organization based in Limerick. This is an excellent opportunity for someone looking to work with a leading multinational company that consistently delivers high-quality results.
Duties and Responsibilities:
* Validation Support: Provide assistance for validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment.
* Technical Expertise: Manage complexity and serve as a technical expert for the Validation process to ensure compliance.
* Problem-Solving: Resolve and manage technical operational problems in area of expertise.
* Innovation and Improvement: Suggest and implement innovation and continuous improvement within the Validation process.
* Team Facilitation: Facilitate successful team behavior within Quality Systems and across functional areas.
* Relationship Management: Manage relationships externally and internally.
* Cross-Functional Support: Build cross-functional and cross-departmental support, fostering overall effectiveness.
* Quality Assurance: Foster harmony within Quality Systems.
* Document Review: Review and approve Validation Master Plans, Protocols, Summary Reports, and other documentation associated with validations.
* Compliance Approval: Ensure all validation activities and documents are authorized and appropriate compliance approval is gained.
* Audit Assistance: Ensure that all validation activities are carried out and reported in a timely manner and assist in audits for compliance.
Education and Experience:
* Regulated Industry Experience: Experience working in a regulated industry carrying out validations.