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Main Objective:
Support computer system validation activities at Arthrex.
Essential Duties and Responsibilities:
Ensure appropriate regulations, such as 21 CFR Part 11, 820 and cGMP regulations, are addressed in validation.
Coordinate, assist and document validation activities; preparation/approval of protocols and reports.
Draft, review and approve local validation and compliance documents supporting GxP computerized systems, and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation. Examples include SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls.
Prepare, assist, or participate in system design, specification development, and design review.
Perform systems FDA validation for QAD and customizations.
Perform revalidation and change control validation related activities.
Ability to apply complex system validation principles to work assignments.
Must be able to function independently, play a leadership role within a cross-functional team and address a variety of moderate to complex problems.
Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change.
Provide training to colleagues and contractors on our approach to systems implementation and validation SOP's.
Assist validation activities of cross functional teams that include technical functions such as Information Systems, Manufacturing and QA Engineering, business owners.
Develop and maintain Validation SOPs, forms, documentation and files.
Coordinate meetings, document issues, action items, meeting notes, do appropriate follow up related to CSV projects.
Incidental Duties:
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
At least two years experience in experience in the validation of computer systems, manufacturing, packaging, equipment and process, as well as utilities, and facilities qualification.
Must have thorough understanding of FDA regulations and computer validation guidance documents
Bachelor's degree in computer science, technology or related field required
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Experience in thorough testing of applications, computerized systems, changes and implementations.
Familiarity with the following systems: MES, QAD, ERP, Document Management, HP Quality Center and Quality Records Management.
Familiarity with GAMP and other approaches to System Development Life Cycles (SDLC), CAPA.
Computer knowledge of 21 CFR Part 11, CFR 820Excellent communication skills and customer service orientation
FDA Compliance experience preferred.
Machine, Tools, and/or Equipment Skills:
PC servers, workstations and laptops. Microsoft environment. Work with standard current computer applications, such as word processing, spreadsheets and data bases.
EOE D/F/W
Arthrex’s corporate headquarters is located in Naples, Florida where visitors will find a vibrant atmosphere of rapid product innovation, medical research and surgeon collaboration. The sprawling campus houses corporate and manufacturing operations, as well as Arthrex’s premier Medical Education Center, which serves as an education destination for surgeons from around the world to learn about new products and techniques through hands-on surgical skills training programs.
Incorporated since 1981, Arthrex has been committed to just one thing: helping surgeons treat their patients better. Arthrex has pioneered the field of arthroscopy and developed more than 6,000 innovative products and surgical procedures to advance minimally invasive orthopedics worldwide.
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Arthrex continues to experience unprecedented growth and demand for our products throughout the world; however, we remain a privately-held company with a family business culture that is committed to delivering uncompromising quality to the healthcare professionals who use our products, and ultimately, the millions of patients whose lives we impact. |
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