Quality Assurance Specialist

Grünenthal; Origgio; Ibrido; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Italy is seeking a Quality Assurance professional to join their Manufacturing & Global Operations team. In this role, you will focus on process validation, change controls, and ensure compliance with GMP standards. Candidates should have around two years of related experience and a degree in a scientific discipline.

Competenze

• Around 2 years of experience in Quality Assurance.
• Comprehensive knowledge of GMP standards and process validation.
• Basic knowledge of regulatory requirements.

Mansioni

• Manage change controls and participate in site trainings.
• Issue and revise Product Quality Reviews and process validation protocols.
• Collect site KPIs and manage regulatory aspects.

Conoscenze

Change control management

Risk assessment management

Knowledge of GMP standards

Fluency in English

Formazione

Degree in Scientific disciplines

Descrizione del lavoro

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 varietyof 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