14 oct
|
Werfen
|
Llissá de Munt
14 oct
Werfen
Llissá de Munt
Overview
Job Summary
The Quality Systems (QS) Engineer is responsible for maintaining the core Quality Management
System (QMS) processes, including Document Control, Change Control, Internal Audit and
Training Management, and ensure the company is compliant with all applicable regulations and
standards. The QS Engineer operates with a high degree of autonomy in the planning,
coordination and exectuion of audits, and, upon qualification through the internal auditor
qualification program, is authorized to conduct internal audits independently. The role serves
also as a subject matter experts (SME) for the QS processes, providing technical guidance and
support across the organization. In addition, the QS Engineer actively contributes to the
continual improvement of the QRA function and supports the effective management of Non-
conformance, Corrective and Preventive Actions (CAPA), and other quality system improvement
initiatives.
Responsibilities
Key Accountabilities
• Organize and coordinate internal and external audits, including planning, execution and
follow-up activities.
• Conduct internal audits upon successful completion of the Internal Auditor Qualification
Program.
• Lead backroom activities during external audits and host the frontroom activities during
internal audits.
• Develop the annual Quality Training Program based on identified organization needs,
support its deployment, and monitor its effective execution.
• Collect, analyse and communicate training feedback to trainers to support the continous
improvement of training content and delivery method.
• Oversee the preparation, implementation and completion of Annual Training Plans.
• Design and develop training materials, and provide guidance and support to other
departments in training-related activities.
• Deliver Quality and GMP-related training sessions across the organization.
• Maintain the Documentation Management System.
• Manage documents of external origin. Participate in the impact assessment
📌 Quality Systems Engineer (Llissá de Munt)
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📍 Llissá de Munt