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 *, 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