Descripción y detalle de las actividades
responsibilities: - develop and coordinate environmental and sterilization plans to comply with applicable regulations.
- provide support on environmental and sterilization validations, including but not limited to the development of protocols and reports.
- file, update, and maintain environmental and sterilization records in accordance with applicable regulations and licenses.
- develop, update, and/or implement sampling plans applicable to environmental and/or sterilization processes.
- audit environmental, manufacturing, and sterilization processes.
- coordinate and follow up on capas, ncmrs, and/or complaints related to sterilization and environmental, as well as the follow-up and risk management evaluation.
- customer communication on any item related to sterilization and environmental issues.
- provide support to qms plans.
experiência y requisitos
- bachelor's degree on microbiology, biochemical engineering, qfb, or similar - experience in medical manufacturing environment conditions and controls - knowledge environmental/sterilization process and applicable standards - knowledge of iso *:*, cfr 21, cofepris, and other applicable standards - bilingual, english 80% - teamwork focus, proactive - computer skills (microsoft office) - internal auditor iso *:* certified
*número de vacantes* 1
*área* calidad
*contrato* permanente
*modalidad* presencial
*turno* diurno
*jornada* tiempo completo
*estudios* titulo profesional
*sexo* indistinto
*disponibilidad p.
viajar* no