Quality Assurance Specialist

Gr?nenthal GmbH; Sesona; Ibrido; EUR 35.000 - 55.000; Tempo pieno

Descrizione del lavoro

A leading company in pain management is looking for a Quality Assurance Specialist to join their international team in Lombardia. In this role, you'll ensure compliance with GMP standards, manage change controls, and participate in the execution of inspections. The ideal candidate is experienced in Quality Assurance, holds a relevant degree, and is fluent in English.

Competenze

• Around 2 years of experience in Quality Assurance.
• Comprehensive knowledge of GMP standards.
• Experience in change control and risk assessment management.

Mansioni

• Management of change controls and site training planning.
• Issuance and revision of Product Quality Review (PQR).
• Participation in self-inspections and CAPA management.

Conoscenze

Knowledge of GMP standards

Change control

Risk assessment management

Process validation

Fluency in English

Formazione

Degree in Scientific disciplines

Descrizione del lavoro

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Quality Assurance Specialist

Department : Global Operations & Production

Job ID : 44645

Professional | Permanent | Full-time | Hybrid

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 variety of challenges, such as :

• Being 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 and 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 licenses
• Collection of site KPIs

What you'll bring to the table

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

• Previous experience in a similar role within Quality Assurance departments (around 2 years)
• Comprehensive knowledge of GMP standards and a previous experience in change control, risk assessment management and process validation, basic knowledge of the local and international legal / regulatory requirements
• Degree in Scientific disciplines
• Fluency in English

Grünenthal is a global leader in pain management and related diseases. As a science-based, fully-integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focusing all of our activities and efforts on working towards our vision of a world free of pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 27countries across Europe, Latin America and the US. Our products are available in approx. 100 countries. In 2023, Grünenthal employed around 4,400 people and achieved revenues of € 1.8bn.

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Quality Assurance Specialist • Lombardia, Varese, Italia