Generate applicable documentation to Automated Equipment Validation of Quality Management System.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- 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 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.
- Support all company safety and quality programs and initiatives.
- Experience in working with Automation Vendors.
- Ensure ongoing compliance with GMP in all practices, recording of events and processes.
- Ensure compliance with all learnings from all GMP training events.
- 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.
- 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.
- Strong working knowledge in the application of quality engineering tools and techniques with key emphasis on GAMP5 and Master Validation Planning.
- Excellent organisation, communication, computer, & presentation skills.
- Excellent initiative, decision-making and be able to work in a core team environment attaining resolutions.
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