Qa Training & Documentation Specialist

24 ott - Parma
Chiesi

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)

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