Quality Validation Engineer Waterford
Reports To: Senior Quality Engineer
- Degree in Engineering/Science discipline.
- 3 to 5 years' experience in a Validation Quality Engineering role.
- Strong working knowledge of Validation Process. Experience in method validation and process characterization an advantage.
Responsibilities of Position
- Strong working knowledge in the application of quality engineering tools and techniques with key emphasis on GAMP5 and Master Validation Planning.
- Generate applicable documentation to Automated Equipment Validation of Quality Management System. Experience in CAPA, NCMR systems, control plans, FMEA's, DOE's is an advantage.
- Write the necessary validation protocols, & amendments of the Quality Management System ensuring compliance with the latest FDA directives / requirements within the Medical Device 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.
- Experience in working with Automation Vendors.
- Other duties as required.
- 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.
For further information on this Quality Validation role in Waterford please contact Bimi Felix on 091730022 / email@example.com
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