Calificacion y Validation Expert en PHARMA QUALITY EUROPE

Calificacion y Validation Expert
PHARMA QUALITY EUROPE | (5) ofertas activas
Pharma Quality Europe (PQE), Empresa Internacional que ofrece servicios de asesoría, consultoría y soluciones integrales de calidad para empresas reguladas del ámbito del LifeScience y particular en el contexto sanitario (Farmacéutico, Químico Farmacéutico, Dispositivos Médicos, Hospitalario y afines).

La Compañía presenta actualmente más de 500 consultores, distribuidos a nivel mundial en sus diferentes sedes operativas/representaciones: Italia, España, Suiza, Alemania, Israel, Rusia, China, Japón, India, USA, México, Brasil y Ecuador.
Guadalajara, México DF, 22 Feb.
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Descripción
Due to a constant growth, PQE is looking for an Expert in facilities, process equipment, utilities and related control systems qualification in the regulated pharmaceutical and medical devices environments.
Responsibilities include:
-Development of qualification plans, user/technical requirements specifications, design qualification reports, test plans, requirements-testing traceability matrixes, qualification summary reports
-Development of installation, operational and performance qualification protocols for equipment and utilities (e.g.: HVAC, Water Systems, Process Gases), according to the current internationally recognized guidelines (e.g.: ISPE, GAMP)
-Development of thermal validation study protocols
-Development of project validation master plans for new sites implementation including detailed Gantt charts with predecessors and resources workload evaluation (advanced Microsoft Project requested)
-Knowledge of the main test instruments suites (e.g.: GE Kaye Validator, Thermal validation studies data loggers, HVAC test instruments, calibration instruments)
-Coordination of junior resources for qualification testing execution and use of test instruments
-Development of risk based assessment at process, component and functional level according to the internationally recognized methodologies (e.g.: FMEA, HACCP)
-Development of calibration and maintenance plans and related instructions
-Development of standard operating procedures
-Advanced knowledge of EU and US GMP

Numero de vacantes: 1
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Requisitos
• Fluent English
• Full availability to travel
• Technical Degree (Engineering, Chemistry, Informatics, Physics, Mathematics)
• Minimum of 3 years’ experience in the drug manufacturing area
• Integrity, strong analytical skills and attention to details

Estudios mínimos
Licenciado
Idiomas
Inglés nivel Alto.
Experiencia mínima
3 años
Disponibilidad para viajar
El 80% del tiempo laboral



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