Descripción y detalle de las actividades
Ensure that validation process is executed and reported according to the Ontex guidelines to ensure an effective change management and a timely implementation.
- Configure validation protocols for each validation process.
- Ensure compliance with validation formats.
- Participate in the execution of the validation phases.
- Coordinate trials and ensure that all resources and roles are available and clear about their tasks.
- Perform the extraction of samples to be evaluated.
- Coordinate with laboratory heads the execution of tests and establish priorities.
- Lead the tests to ensure their success and report the results obtained.
- Participate in the analysis and verifications of the results obtained based on the samples performed.
- Create work instructions.
- Ensure that the processes comply with the required regulations (21CFR820, ISO 9001, ISO 13485).
Experiência y requisitos
- Bachelor's degree (university or equal through experience) in engineering / science:
Knowledge about business processes and project management
- Fluent in English
- Basic interested and knowledge of IT systems
- 2-year experience in a quality or technical environment
- Be able to work with cross functional teams and in a matrix structure - Analytical skills and communication skills
- Project management in cross functional teams
- Multifunctional business relations with several departments of Raw material suppliers and equipment suppliers
- Use and knowledge of different IT tools
Beneficios
- Incentivos de acuerdo a la LFT
- Caja de ahorro
- Comedor
- Servicios medicos en planta
- Fondo de ahorro
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario**
- L - V
**Estudios** Carrera con título profesional
**Disponibilidad p. viajar** No