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.
Execute software validation activities for compliance with regulatory agencies (FDA, QSR, ISO) in Jabil Healthcare Baja sites. Using current software validation methodologies, risk analysis, validation protocols and reports. Update and maintain site software master validation plan administration, including Software Master List, software change control, and template and format management.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
· Update and maintain the site software validation and revalidation master plan.
· Work with companies on any computer software validation activities as needed.
· Maintain and continue to update the site software validation procedure, validation protocol and reporting templates
· Ensure that all requirements of ISO 13485, QSR part 820, 21CFR part 11 related to software control and master site validation plan are properly met.
· Support software validation activities at Jabil Healthcare around the world when needed.
· Participate in CAPA, NMR and customer complaints related software validation activities.
Bachelor's degree preferred; or equivalent combination of education and experience.
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.
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