GMP QA Training & Documentation Lead

Biopharma Careers; Parma; In loco; EUR 32.000 - 40.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension plan

Private medical insurance

Wellbeing programme

Relocation assistance

Flexible benefits

Remote work options

Descrizione del lavoro

Chiesi is seeking a Training & Documentation Specialist for Global TechOps & Supply in Parma. You will oversee training and documentation systems, implement a new document management project, and coordinate governance for training software while ensuring regulatory compliance and audit readiness.

You will liaise with cross-functional teams, manage access controls, and support regulatory audits, contributing to a robust quality framework and continuous improvement efforts.

Competenze

• Fluent English (both written and spoken).
• Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering).
• 5+ years in manufacturing/pharma QA with document and training experience.
• Knowledge of GMP, EU/FDA guidelines, and regulatory requirements.
• Ability to manage multiple projects and drive compliant processes.

Mansioni

• Issue procedures for the document management system and requirements.
• Archive and manage the Central Archive of documentation.
• Manage the EDMS to stay updated and regulatory compliant.
• Provide user training for the electronic documentation system.
• Support users and monitor documents for expiration and updates.
• Participate in governance for the training management system.

Conoscenze

Fluent English

Project management

Team collaboration

Analytical thinking

Formazione

Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering)

Strumenti

Training Management System (LMS)

Electronic Documentation Management System (EDMS)

GMD documentation system

Descrizione del lavoro

Chiesi is seeking a Training & Documentation Specialist for Global TechOps & Supply in Parma. You will oversee training and documentation systems, implement a new document management project, and coordinate governance for training software while ensuring regulatory compliance and audit readiness.

You will liaise with cross-functional teams, manage access controls, and support regulatory audits, contributing to a robust quality framework and continuous improvement efforts.