Accountable for the supervision of the production process and the relevant team in a specific medium-sized production or packaging area during the shiftAreas of Impact:Production/packaging processPerforms operations related to the production of single and multi-component preparations, in compliance with the prescribed procedures with the principles of GMP.Advanced operation, assembly and adjustment of simpler and more complex production equipment, device parameters setting. Deputy of supervisor in time of absence.Job Aspect: 1. Performs the full range of established procedures such as: operating machines and manipulation with material, producing and checks on daily basis necessary documentation in line with data integrity and GMP, monitoring processes in scope, keep stock adherence2. Monitors processes parameters to ensure compliance and eliminate deviations, Coordination of production processes3. Resolves routine issues - trouble shooting and monitors such activities for other colleagues4. Has developed expertise, typically through a combination of job related training and considerable on-the-job experience5. Typically acts as a lead, coordinating the work of others, but is not a supervisor (may act as supervisor deputy in time of absence)6. Performs regular operational controls of production lines7. Foreman - is responsible for work organization on operational basis; in case of supervisor absence performs shift handover, tracks relevant shift records, observe technology / GMP/ EHS compliance at work place8. Provide on-the.job training to other operators9. Works autonomously within established procedures and practices10. Has developed a specialized level of skill to perform assigned tasks Responsibility for checking the documentation of the product series in terms of completeness of entries, confirming the compliance of the production process with the requirements of acting country law, EU law, GMP, HACCP requirements and the applicable internal documentation of the Company ; 11. Proper operation and taking care of the technical condition, immediate reporting of defects; Ongoing informing the supervisor about the progress of tasks and possible difficulties in their performance. Immediate notification of any irregularities and abuse to the detriment of the Company and events that may affect the quality of the productCompetencies:Ability to follow process and proceduresAttention to detail, Learning Agility, Collaboration and Communications skills, Organizational skillsBasic training skills (educate and mentor other operators), GMP knowledge on the proper levelDigital awareness, excellence in action, adaptation to change, good organization of own work, ability to work under time pressureCapabilities / Technical Skills:As per skills matrix per site processAreas of focus:assembly, washing processes, documentation, work with control systems (MES etc.), IPC controls,manipulation with material, stock adherence, OEE principles, GMP/EHS/FP/SOPs alignment, clean work place, daily work organization, training skillsQualifications / Trainings:GMP certificationQuality / work procedures trainingsEHS qualificationsIT systems qualifications upon required level
How you’ll spend your day
• Cumplir los lineamientos de las Buenas Prácticas de Documentación, Integridad de datos y las Buenas Prácticas de Fabricación que aplican durante el ejercicio de las actividades que correspondan.
• Realizar un buen manejo de las materias primas, materiales y producto a granel utilizados en los procesos productivos, así como el correcto manejo del producto terminado.
• Realizar para cada lote las devoluciones de los materiales y la conciliación de materias primas y materiales, justificando las mermas.
• Cumplir con los horarios establecidos de entrada y salida de la jornada laboral.
• Cumplir con las reglas de seguridad e higiene.
• Mantener limpio y ordenado su equipo y área de trabajo.
Your experience and qualifications
• Registrar correctamente en los procedimientos de fabricación del producto y bitácoras los puntos relacionados con el proceso que está realizando, recordando siempre la premisa de “actividad realizada / actividad registrada”.
• Mantener los equipos e instalaciones correspondientes al área de solidos orales en buen estado, en caso de alguna falla o mal funcionamiento, informar a su supervisor y/o solicitar la reparación.
• Ejecuta los procesos de Fabricación y Limpieza de las áreas de: Granulado, Mezclado y Recubrimiento.
Escolaridad: Secundaria / Nivel Medio Superior
Experiencia: Minima de 1 año en posicione similares
Conocimientos en mecánica industrial básica de buenas prácticas de abricación.
Conocimiento sobre Limpieza y sanitizacion de Cuartos Limpio, conocimiento sobre el ingreso de materiales a área de Proceso
Alto sentido de orden y limpieza, tanto personal como en el desempeño de sus labores.
Disponibilidad para rolar en turnos.
Dinámico y creativo.