QA Training & Documentation Specialist

Overview

You will support Global Technical Operations & Supply by governing training and documentation systems. You'll implement the new electronic document management project and ensure compliance with regulatory standards. The role sits at the crossroads of quality, training, and regulatory affairs, enabling consistent, documented processes across sites. You will partner with cross‐functional teams to drive governance and continuous improvement in documentation and training. This opportunity lets you shape how we manage critical knowledge and stay compliant at scale.

Retribuzione / Benefits

• pension
• private medical insurance
• wellbeing programme
• flexible benefits programme
• relocation support
• remote work options

Responsabilità

• Describe and issue procedures for the document management system and its requirements
• Archive and manage the Central Archive of documentation
• Maintain the Electronic Documentation Management System (EDMS) aligned with regulatory requirements
• Provide user training for the EDMS
• Support users in the document management system usage
• Monitor document expiration and ensure timely confirmation or revision
• Quality check and verify documents
• Distribute documents to suppliers
• Ensure compliance of training and documentation with regulations
• Participate in governance for the training management system
• Evaluate and authorize access to computerized systems in the GMD area
• Support audits by regulatory authorities or clients
• Support Corporate Quality audits
• Enter training event data into the training management system and report it
• Configure job roles and training plans
• Archive general training documentation
• Support LMS users
• Organize training courses per Training Program
• Extract and process training data from the LMS
• Support training improvement projects in GMD

Requisiti fondamentali

• Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering)
• At least 5 years in pharmaceutical/biopharmaceutical manufacturing with a strong QA track record
• Excellent knowledge of EU and FDA pharmaceutical guidelines
• Proven ability to manage multiple projects
• Specialized expertise in GMP compliance improvement processes
• Strong teamwork and constructive collaboration
• Analytical problem-solving with risk assessment
• Fluent English (written and spoken)
• teamwork
• problem-solving
• communication
• Electronic Documentation Management System (EDMS)
• Training Management System
• Learning Management System (LMS)