GMP Training & Documentation Manager - Remote

Biopharma Careers; Parma; In loco; EUR 55.000 - 85.000; Tempo pieno

Vantaggi offerti da questo lavoro

Healthcare benefits

Relocation support

Flexible working arrangements

Remote work options

Tax assistance for foreign colleagues

Descrizione del lavoro

Chiesi, headquartered in Parma, Italy, is seeking a Training & Documentation Coordinator for Global TechOps & Supply. You will manage GMP training and documentation, coordinate a system-wide document management upgrade, and ensure compliance with EU/FDA guidelines across the Parma plant.

The role requires a degree in scientific subjects, 5+ years in pharma manufacturing, GMP expertise, and fluent English. Relocation and a comprehensive benefits package are offered.

Competenze

• Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering)
• At least 5 years of experience in manufacturing sites within the pharmaceutical/biopharmaceutical sectors (QA, Production, Process Technology)
• Excellent knowledge of pharmaceutical guidelines (EU and FDA)
• Specialized expertise in GMP compliance improvement processes
• Fluent English (written and spoken)

Mansioni

• Analyze and gather the training needs of Parma Plant personnel with respect to GMP topics
• Organize general GMP courses for TechOps staff, directly or with external consultants
• Issue the TechOps training programme and prepare the related annual report
• Participate in governance team for the training management system and ensure regulatory alignment
• Support projects aimed at improving TechOps training processes
• Manage the documentation system in compliance with GMP and regulatory bodies
• Participate in governance team for the current document management system
• Contribute to the implementation project for the new document management system
• Supervise and support TechOps QA archive management
• Provide support during Corporate Quality audits and regulatory/customer audits
• Evaluate and authorize access requests to computerized systems in TechOps
• Monitor training and documentation KPIs

Conoscenze

GMP compliance

English fluency

Quality Assurance

Formazione

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

Descrizione del lavoro

Chiesi, headquartered in Parma, Italy, is seeking a Training & Documentation Coordinator for Global TechOps & Supply. You will manage GMP training and documentation, coordinate a system-wide document management upgrade, and ensure compliance with EU/FDA guidelines across the Parma plant.

The role requires a degree in scientific subjects, 5+ years in pharma manufacturing, GMP expertise, and fluent English. Relocation and a comprehensive benefits package are offered.