Descripción y detalle de las actividades
- Coordinate and lead Document Control and Quality System Records.
- Coordinate and lead the process of controlling changes in the Quality System as applicable.
- Coordinate and lead the efforts to guarantee that the procedures, work instructions, and templates used in Plant operations are aligned to Corporate's.
- Coordinate and manage the activities of personnel under his/her supervision in order to achieve individual and Quality System objectives.
- Create and monitor a development plan for personnel under his/her supervision to guarantee they are prepared and qualified to meet their responsibilities.
- Guarantee that personnel under her/his supervision comply in a timely manner with the required training.
- Guarantee that personnel under her/his supervision comply with the established safety regulations.
- Review the "Issued Specification Report" daily, in order to detect revision changes in either the design specifications, process documents or inspection criteria and distribute the revised documents among the appropriate personnel.
- Maintain a record of document controlled copies distributed in the Plant.
- Maintain an inventory of controlled copies of external documents - Monitor and comply with safety procedures and politics.
- Provide support, along with personnel under her/his supervision, as required during the Audits performed in Plant Operations.
- Provide information as required for QSRB or Management Review meetings in a timely manner.
- Serve as Internal auditor in the audit process when required.
- Provide the training in the Agile system for change process when required.
Experiência y requisitos
- Advanced English - Valid VISA - Bachelor's degree completed or in process in Industrial Engineering, Chemistry, Quality or similar.
- Use of software packages, Windows, Excel, Power Point, Word.
- Bachelor's degree - 2+ years medical device/pharmaceutical/biotech configuration assurance or related experience - Familiarity with modern ERP systems, PLM systems and/or manufacturing documentation (e.g., BOM, item masters, etc.)
- Demonstrated proficiency using Microsoft Word, PowerPoint, and Excel - Proficient using the following software systems: Agile, SAP and Winshuttle.
- Excellent analytical, verbal communication and writing skills - Ability to work in a team environment as well as independently and with mínimal supervisión - Exhibits high degree of initiative and good judgment - Knowledgeable in using Agile PLM Import Tool and competent in Agile searches
**Número de vacantes** 1
**Área** Calidad
**Contrato** Temporal
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario** Lunes a Viernes 7:00 a.m. a 5:30 p.m.
**Estudios** Carrera Profesional
**Inglés **Hablado: 80%, Escrito: 80%
**Sexo** Indistinto
**Disponibilidad p. viajar** Si