- Generate and execute applicable validation documentation for Moulding, Assembly, Test Equipment, Computerized Systems, Facilities and Supplier Validation within the Quality Management System.
Key Responsibilities and End Results: (Essential responsibilities include but are not limited to the following):
- Generate applicable documentation to Automated Equipment Validation of Quality Management System.
- Write the necessary validation protocols, & amendments of the Quality Management System ensuring compliance with the latest Regulatory Agencies (HPRA, FDA) directives / requirements within the Medical Device and Pharma Sector.
- Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
- Development of validation projects.
- Support the implementation of Company Policies and GMP.
- Support all company safety and quality programs and initiatives.
- Experience in working with Automation and Moulding Vendors.
- Ensure ongoing compliance with GMP in all practices, recording of events and processes.
- Ensure compliance with all learnings from all GMP training events.
- Perform and generate Risk Assessment documents for regulated processes within the scope of the QMS.
- Knowledge and use of LEAN 6 sigma tools for problem solution.
- Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
Job Specifications: The minimum education and experience required to perform this job competently.
- Degree in Engineering/Science discipline.
- 5+ years’ experience in a Validation Quality Engineering role.
- Strong working knowledge of Validation Process. Experience in method validation and process characterization an advantage.
- Strong working knowledge in the application of quality engineering tools and techniques with key emphasis on Eudralex, ISO13485, GAMP5 and FDA Pharma and medical devices regulations.
- Excellent organisation, communication, computer, & presentation skills.
- Excellent initiative, decision-making and be able to work in a core team environment attaining resolutions.
- Performance and Results driven.
Organization Linkages: List the titles of individuals and organizations with which this position has the most frequent and significant contact. Briefly describe the nature of those contacts.
- Reports to Senior Quality Engineer.
- Department Managers and Employees.
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