At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world’s leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.
Descripción del Trabajo
Contractor - 12 months
- 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.
3.0 Job Specifications : The minimum education and experience required to perform this job competently.
- 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 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.
4.0 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.
Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.
Validation of Assembly and Moulding Processes
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