Calificacion y Validation Expert
PHARMA QUALITY EUROPE
Ciudad de Mexico, México
hace 6 días
source : PMFARMA

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
  • Edad máxima para el puesto : 40 años.

    Requisitos :
  • Fluent English
  • 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
  • Nivel de estudios mínimo requerido : Licenciado Nivel de Inglés mínimo requerido : Leído : Bueno Escrito : Bueno Hablado : Bueno Experiencia profesional mínima requerida : 3 años Disponibilidad para viajar requerida : El 80% del tiempo laboral

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