MICROBIOLOGY LAB MANAGER en PROARCAI

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MICROBIOLOGY LAB MANAGER

Fecha de la oferta: 14 Jun.
Empresa que publica esta oferta: PROARCAI
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Número de vacantes: 1
Provincia/s: Madrid

Descripción

Descripción: Global leading pharmaceutical company is seeking a Manager for the Microbiology Laboratory who leads all aspects of microbiological assay and environmental monitoring activities to support manufacturing and development activities of the site located in Madrid. He/she will ensure compliance with the established SOPs, cGMP and all regulatory agencies, while providing leadership to the microbiological lab team as well as communicating the company vision and values.

Responsabilities

-Lead and develop the Microbiology/EM team that supports the daily operations of the Manufacturing and Process Development group
-Ensure compliance to cGMP regulations for all processes and equipment related to the Microbiology Laboratory activities.
-Establish and improve key metrics (KPIs) around Microbiology and Environmental Monitoring testing.
-Identifies and assigns or leads Continuous Improvement Projects.
-Perform analysis and interpretation of data generated by the team. Prepare/ review protocols and final reports as needed.
-Create/Review/Approve SOPs, laboratory records and other related documentation.
-Lead or provide SME input to investigations where microbiological expertise input is needed.
-Support/ participate new product / method transfers to the site. Develop and execute plans for test method validation/verification, raw material or products sampling plan.
-Provide technical advice and support for internal and external interactions such as regulatory audits/inspections, local or global meetings.
-Liaise with QA to leverage knowledge and experience not being available in house.
Tipo de contrato: INDEFINIDO

Requisitos

Requisitos: • University Degree (Life Science or equivalent preferred)
• 5+ years of experience in Quality Control (microbiology lab)
• 5+ year experience with cGMP, aseptic techniques, Environmental Monitoring, Microbiology Lab equipment, software and data integrity.
• Excellent technical expertise in Microbiology and Environmental Monitoring fields
• Proven experience in managerial or supervisory role
• Proven track record in leading organizational change
• Advanced level of English spoken, written and understood.
• Knowledge and understanding of cGMPs including FDA and EU regulations.
• Knowledge and experience in cGMP CAPA, root-cause analysis, risk assessment and investigation tools and techniques.
• Excellent communication, organization, analytical and technical writing skills
• Good knowledge of method development, validation and method transfer principals.

Nivel de estudios mínimo requerido: Diplomado
Idiomas requeridos: Inglés nivel Perfecto.
Experiencia profesional mínima requerida: 5 años
Disponibilidad para viajar requerida: Ninguna

Comparte esta oferta:

Esta oferta ha recibido 38 inscripciones.