R&D Microbiological Development Scientist I

hace 3 semanas

León, España PCI Pharma Services A tiempo completo

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

DENOMINACIÓN / PUESTO: TÉCNICO DESARROLLO MICROBIOLÓGICO

DEPARTAMENTO: I+D DESARROLLO MICROBIOLÓGICO

REPORTA A: Responsable de DESARROLLO MICROBIOLÓGICO

FUNCIONES:
  1. Desempeñar sus funciones siguiendo los criterios de calidad, las normas de seguridad y salud.
  2. Realizar las funciones de su puesto atendiendo a los Valores de comportamiento establecidos por la empresa.
  3. Trabajar de acuerdo con la normativa GMP.
  4. Reportar el trabajo realizado y las necesidades del departamento al Responsable de Desarrollo.
  5. Supervisión y control del trabajo desempeñado por el personal a su cargo.
  6. Elaboración, revisión, aprobación y control de la documentación GMP generada en el laboratorio de desarrollo microbiológico.
  7. Mantener actualizada la documentación GMP que aplique al departamento de desarrollo microbiológico.
  8. Verificación y gestión de nuevas monografías y actualizaciones en farmacopeas.
  9. Desarrollo y/o optimización de métodos nuevos o ya existentes.
  10. Gestión, investigación y participación en las acciones de los eventos de calidad detectados en el departamento de desarrollo microbiológico: resultados fuera de especificaciones (OOS), fueras de tendencias (OOT), desviaciones, controles de cambios (CC), Acciones correctivas y/o preventivas (CAPA), reclamaciones, rechazos y retiradas.
  11. Revisión de las actividades y registros generados en el laboratorio de desarrollo microbiológico. Interpretación de resultados.
  12. Control de stock de materiales necesarios en el departamento de desarrollo microbiológico.
  13. Administración de los recursos materiales y las existencias del laboratorio.
  14. Ejecución de pruebas microbiológicas y realización de análisis y muestreos si se requiere.
  15. Muestreo ambiental de salas limpias y de personal.
  16. Gestión y control de muestras.
  17. Formación inicial y continuada del personal de Laboratorio de desarrollo microbiológico, en las diferentes técnicas instrumentales y procedimientos que apliquen.
  18. Gestión de la calibración, verificación y mantenimiento de los equipos del departamento.
  19. Mantener la organización y limpieza del laboratorio.
  20. Preparación de la documentación necesaria para procesos de registro y apoyo para la contestación de cartas de deficiencias de clientes o autoridades sanitarias.
  21. Participación en auditorías internas y externas (clientes o autoridades sanitarias competentes) así como visitas que tengan lugar dentro del laboratorio de control de calidad microbiológico.
  22. Colaboración para el establecimiento de planes de medidas correctivas y/o preventivas.

Join us and be part of building the bridge between life changing therapies and patients.

Let’s talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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