QA System Specialist

Experteer Italy; Origgio; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a dynamic individual to join their Quality Assurance team. This role involves managing change controls, participating in regulatory aspects, and ensuring compliance with GMP standards. You'll collaborate with a dedicated team to enhance product quality and contribute to the company's mission of delivering high-quality medicines. If you possess a scientific background and a proactive mindset, this opportunity offers a chance to grow within an international environment focused on continuous improvement and collaboration.

Competenze

• Basic knowledge of legal/regulatory requirements is essential.
• Experience in GMP standards and risk assessment management is required.

Mansioni

• Manage change controls and participate in site trainings.
• Issue and revise Product Quality Reviews and Master Batch Records.
• Cooperate in regulatory aspects to maintain manufacturing license.

Conoscenze

Knowledge of GMP standards

Change control management

Risk assessment management

Process validation

Fluency in English

Formazione

Degree in Scientific disciplines

Descrizione del lavoro

Our people in Manufacturing & Global Operations share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future.

What the job looks like

Each day you'll enjoy a varietyof challenges, such as:

• Be part of the Quality Assurance team, reporting into the Head of QA Systems
• Management of change controls
• Participation in planning and execution of site trainings
• Issuance and revision of Product Quality Review (PQR)
• Participation in planning and execution of self-inspections together with CAPA management
• Revision of Master Batch Records
• Issuance of process validation protocols and reports
• Participation in risk assessment management
• Cooperation in the revision of qualification and validation documentation
• Overview on Quality Agreement with customers
• Participation in management of regulatory aspects to maintain required manufacturing license
• Collection of site KPIs

What you'll bring to the table

To make the most of this role and truly thrive, you should have:

• Basic knowledge of the local and international legal/regulatory requirements
• Comprehensive knowledge of GMP standards and a previous experience in change control, risk assessment management and process validation
• Degree in Scientific disciplines
• Fluency in English