Descripción y detalle de las actividades
- Ensure implementation of document control procedure across the Quality System.
- Maintains document archival and record retention program.
- Assist change owners, document authors, reviewers, and approvers while creating, changing, or obsoleting documents.
- Assign specific running numbers for IPD-SD QMS documents and records.
- Initiate periodic review of site level Quality Documents.
- Notify and initiate the site level document impact assessment upon update of Global or business procedures.
- Provide ongoing consultations and awareness trainings to new hires and existing associates on emphasis on GDP, and use of Document Management System in IPD-SD.
- Act as a Quality Record coordinator, responsible for overseeing the execution of quality record retention activities for a quality group / site.
- Act as a ECR Requester and Document Contributor for QMS documents and records and Participates in the coordination, review, approval of new and revised documents
- Work with Subject Matter Experts (SME) to identify training needs.
- Create, update and maintain site level C2C training curriculum in C2C system.
- Training and mentoring: Training employees and LMS administrators on how to use the LMS.
- Content management: Uploading new documents and training presentations into the LMS
- Data collection: Collecting data on overdue/pending training courses to measure training compliance and other required metrics.
- Report creation: Creating, maintaining, and distributing LMS reports as necessary.
- Troubleshooting: Acting as a liaison with LMS programmers to troubleshoot problems or changes
- Training record management: Creating, assigning, and tracking training records and requirements
- Course collaboration: Working with SME to make courses and course content functional in the LMS.
- System expertise: Serving as a system expert and proactively solving system issues.
- Access coordination: Coordinating access to the LMS for employees and external resources
Experiência y requisitos
- _ Bachelor Degree_ Engineering or administrative career
- 2 to 3 years of Experience in similar rol.
- Advanced English communication skills
- Team player with excellent interpersonal and communication skills.
- Disciplined and well-organized.
- Computer proficiency with preferably sound knowledge in Microsoft word, Excel, and PowerPoint
- Good working knowledge of medical device regulations and practices (ISO 13485, 21 CFR 820 and 21 CFR 11)
- Experience in electronic DMS (e.g. SAP) and electronic Learning Management system (e.g.C2C)
Beneficios
- Beneficios de acuerdo a la LFT
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario**
- Tiempo completo
**Estudios** Carrera con título profesional
**Inglés **Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p. viajar** No