GMP Training & Qualification Lead (80-100%)

Ophtafarm AG

Hettlingen

Presencial

CHF 120.000 - 180.000

Jornada completa

hace 34 horas
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Ventajas ofrecidas por este puesto de trabajo

An attractive pension scheme
Free parking
Convenient public transport access

Descripción de la vacante

Ophtapharm AG in Hettlingen near Winterthur seeks a Manager Training & Personnel Qualification (80-100%). You will own the GMP training framework, set qualification standards, and drive risk-based curricula across Production, Quality, QC and Microbiology.

You will modernize training processes with LMS/eQMS, ensuring inspection readiness and patient safety while collaborating with cross-functional leaders to strengthen product quality and compliance.

Formación

  • Experience in GMP-regulated pharmaceutical manufacturing with sterile or aseptic operations.
  • Experience in training, personnel qualification, competency management or related GMP quality systems.
  • Good knowledge of FDA, EU GMP and Annex 1 requirements within pharmaceutical manufacturing.
  • Experience with LMS, eQMS or comparable digital quality systems.

Responsabilidades

  • Own and evolve the site-wide GMP training, competency and personnel qualification framework.
  • Define and govern qualification standards, certification and requalification programs.
  • Lead risk-based training curricula, competency assessments and qualification pathways.
  • Drive modernization and digitalization of training processes and management systems.
  • Act as site expert for GMP training, partnering with production, quality, QC, microbiology and engineering.

Conocimientos

GMP training
Personnel qualification
Competency management
Quality systems

Educación

Pharmacy degree
Pharmaceutical Sciences
Microbiology
Biotechnology
Engineering

Herramientas

LMS
eQMS

Descripción del empleo

Ophtapharm AG in Hettlingen near Winterthur seeks a Manager Training & Personnel Qualification (80-100%). You will own the GMP training framework, set qualification standards, and drive risk-based curricula across Production, Quality, QC and Microbiology.

You will modernize training processes with LMS/eQMS, ensuring inspection readiness and patient safety while collaborating with cross-functional leaders to strengthen product quality and compliance.

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