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CVS Computer Validation Specialist

Req ID: J2315460

  • Ubicación
    Chihuahua, Chihuahua, Mexico
  • Categoría Grupo de Servicios de Diseño
  • Publicado viernes, 22 de abril de 2022
  • Tipo Tiempo completo
  • Tipo de Empleo Empleado Permanente

Descripción del Trabajo

JOB SUMMARY
As Computer Validation Specialist you will be the expert on the site compliance with the medical regulatory requirements applicable to all the customers of the health care medical sector. Will have ownership of several activities related with the documentation, training, internal auditing and support users from functional departments about the Computer Software Validation.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Create / update / correct CSV Medical Documentation
• Create / update / correct CSV Medical records in JDOC
• Coordination of meetings with users and stake holders.
• Deep knowledge of CSV according with ISO-13485 and FDA part 11 regulatory rules.
• Assure that the requirements from ISO 13485, QSR Part 820 and 11 related with control of Software and Validation Master Plan for Software are properly followed.
• Follow the Risk Analysis program for Software Validations.
• Training of site and corporate tools, processes, and service delivery.
• Perform training in Validation requirements under a regulated environment following CFR Part 820, 11, ISO 13485 and GAMP 5.
• Participation and coordination of work schedules, priorities for CSV Medical documentation related tasks and services.
• Compliance with regulatory requirements.
• Give support in the Audits from 1st, 2nd, 3th parties.
• Be part of the Internal Audit Team.
• Understand and embrace the business and Health Care strategic direction.
• Participate in the exchange of ideas and information within the department and other functional departments (related with CSV Medical Documentation).
• Provide regular updates to appropriate managers.
• Exchange knowledge and information with other Jabil facilities to ensure best practices are shared throughout the Jabil organization.
• Engage with internal customers to evaluate issues and opportunities for improvement in regards medical regulations.
• Analytic behavior, self managed, goal oriented.
• Organized, document oriented.
• Excellent written and verbal communication skills.
• Interpersonal skills in working with the customer, management and technical teams in a “self starter” role .
• Strong attention to detail.
• May perform other duties and responsibilities as assigned.

MANAGEMENT & SUPERVISORY RESPONSIBILITIES

• Typically reports to IT Supervisor.
• Job is NOT directly responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).

JOB QUALIFICATIONS
KNOWLEDGE REQUIREMENTS

• Demonstrated knowledge and understanding of Risk Management for computerized systems, applying the GAMP Categories in practice, GAMP - principles and practical approaches.
• Demonstrated knowledge and understanding of FDA 21 CFR Part 820, Part 11 Electronic Records / Electronic Signatures, including the current FDA interpretation, and how to meet these requirements in practical and effective ways.
• Demonstrated knowledge and understanding of ISO-13485 principles and practical approaches.
• Advanced level English skills
• Interpersonal skills in working with the customer, management and technical teams.
• Excellent written and verbal communication skills.
• Effective presentation skills.
• Strong attention to detail.

Must demonstrate self-sufficiency on the following skills/competencies:
• Has the ability to follow written and verbal directions.
• Has speaking /communication skills in front of audience.
• Has the ability to work effectively under pressure with constantly changing priorities and deadlines.
• Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail.
• Business Relationship Management – Practices building strong relationships with business, operations, and other IT groups.

Must be able to acquire the following skills/competencies under direction of others:
• Accountability – Accounts for his/her activities, accepts responsibility for them, and to discloses the results in a transparent manner.
• Action/Results Oriented - Brings full energy to things he/she sees as challenging; enjoys working hard; can act with a minimum of planning; seizes more opportunities than others.
• Business acumen - Knows how the business works; demonstrates knowledge in current and possible future policies, practices, trends, technology, and information affecting his/her business and organization; knows the competition; understands how strategies and tactics work in the marketplace.
• Detail oriented - Has an eye for details and makes a conscious effort to understand the actual cause behind an occurrence.
• Emotional intelligence - Has the ability to monitor his/her own and other people's emotions, to discriminate between different emotions and label them appropriately, and to use emotional information to guide thinking and behavior.
• Presentation Skills - Is effective in a variety of formal presentation settings: one-on-one, small, and large groups, with peers, direct reports, and bosses.
• Sense of urgency - Acts with the realization that efficiency is vital to success, and makes decisions and drives activities in the organization to meet important windows of opportunity.
• Business results orientation - Understands the process of figuring out how to get the right requirements, no matter the challenges faced, and stays resolutely focused on the core principles of gaining alignment and achieving clarity. Ensures that the project and efforts are consistently focused on delivering value for the organization.
• Communication skills - Is able to convey information to another effectively and efficiently.
• Decision making (problem solving) - Is able to forecast the outcome of each option, and based on all these items, determine which option is the best for that particular situation.
• Learning agility - Has the ability to learn, grow, and change over time and consequently develop new skills, rather than simply enhance those that he/she may already have.
• Teamwork - Works collaboratively with a group of people in order to achieve a goal.
• Risk and issues management - Understands the process of identification, analysis, assessment, control, and avoidance, minimization, or elimination of unacceptable risks and/or issues.
• KPAs, metrics and SLA tracking - Understands and applies the tools and techniques to define, measure and control the performance of the project.

EDUCATION & EXPERIENCE REQUIREMENTS
• Bachelor’s degree required; degree in Computer Science, Engineering or Business discipline preferred.
• 0 to 2 year IT experience preferred or an equivalent combination of education, training or experience.

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