Senior QA Systems Specialist

Gr?nenthal GmbH; Origgio; In loco; EUR 37.000 - 40.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus (performance-based)

Equal employment opportunities

Descrizione del lavoro

Grünenthal GmbH in Italy (Lombardia) seeks a Quality Assurance professional for permanent, on-site work in Global Operations & Production. The role focuses on change controls, site trainings, PQRs, CAPA, and qualification/validation documentation to ensure GMP-compliant manufacturing.

Ideal candidates have 3–5 years QA experience in pharma, a degree in a scientific discipline, and strong regulatory knowledge. A performance-based annual bonus is offered.

Competenze

• Degree in scientific disciplines is required.
• 3–5 years of experience in Quality Assurance within the pharmaceutical sector.
• Knowledge of local and international regulatory requirements and GMP standards.
• Strong communication and interface management skills.

Mansioni

• Management of change controls.
• Planning and execution of site trainings.
• Issuance and revision of Product Quality Review (PQR).
• Participation in CAPA management and self-inspections.
• Revision of Master Batch Records.
• Issuance of process validation protocols and reports.
• Participation in risk assessment management.
• Revision of qualification and validation documentation.
• Overview of Quality Agreement with customers.
• Management of regulatory aspects to maintain manufacturing licenses.
• Collection of site KPIs.

Conoscenze

Regulatory knowledge

GMP knowledge

Communication

Formazione

Degree in scientific disciplines

Descrizione del lavoro

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Department: Global Operations & Production

Job ID: 45317

Pay Range (full time): EUR 37.000 - 40.000

Professional|Permanent|Full-time|On-Site

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:

• 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 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:

• degree in Scientific disciplines
• 3–5 years of experience in Quality Assurance positions within the pharmaceutical sector
• knowledge of the local and international legal/regulatory requirements and GMP standards
• competency in communication and interfaces management

Our pay ranges are based on an objective, gender-neutral job evaluation system. The final salary offered is determined based on factors like, but not limited to, relevant education, skills, experience, certifications, geographic location, and business or organizational needs. Your compensation package will include a performance-based annual bonus.

Grünenthal offers equal employment opportunities. Recruitment will take place without distinction with regard to religion, gender, sexual orientation, age, origin, disability or other relevant categories.

Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned 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 focussing 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 28 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2024, Grünenthal employed around 4,300 people and achieved sales of € 1.8 billion.