QA Systems Specialist

Gr?nenthal GmbH; Lombardia; Ibrido; EUR 37.000 - 43.000; Tempo pieno

Descrizione del lavoro

Grünenthal GmbH in Italy's Lombardia region seeks an experienced Quality Assurance professional to coordinate Change Control, ensure GMP compliance, and lead QA activities across product quality reviews and process validation with cross-functional teams.

The role requires a degree in scientific disciplines, 3+ years in pharmaceutical QA, and strong communication skills to drive risk management and regulatory readiness at the site.

Competenze

• Degree in Scientific disciplines.
• Minimum 3 years of experience in Quality Assurance positions within the pharmaceutical sector.
• Knowledge of local and international GMP standards and regulatory requirements.
• Strong communication and interfaces management.

Mansioni

• Coordinating Change Control processes, ensuring timely assessment, implementation and effectiveness verification
• Supporting the development and execution of site training plans to ensure compliance with GMP and quality requirements
• Coordinating the preparation, review and approval of Product Quality Reviews (PQRs), identifying trends and improvement opportunities
• Planning and leading self-inspections, facilitating CAPA definition, implementation and effectiveness monitoring
• Providing QA oversight for the review and approval of Master Batch Records and associated GMP documentation
• Leading the preparation and review of process validation protocols and reports in collaboration with cross-functional teams
• Facilitating risk assessment activities and promoting quality risk management principles across site operations
• Providing strategic QA support for qualification and validation lifecycle activities
• Overseeing Quality Agreements with customers and external partners, ensuring alignment with regulatory and business requirements
• Supporting regulatory compliance activities and maintaining readiness for inspections and manufacturing license requirements
• Monitoring and trending site Quality KPIs, identifying areas for improvement and driving related action plans
• Acting as a key QA interface with internal stakeholders, promoting a culture of quality, compliance and continuous improvement

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 - 43.000

Professional | Permanent | Full-time | On-Site

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:

• Coordinating Change Control processes, ensuring timely assessment, implementation and effectiveness verification
• Supporting the development and execution of site training plans to ensure compliance with GMP and quality requirements
• Coordinating the preparation, review and approval of Product Quality Reviews (PQRs), identifying trends and improvement opportunities
• Planning and leading self-inspections, facilitating CAPA definition, implementation and effectiveness monitoring
• Providing QA oversight for the review and approval of Master Batch Records and associated GMP documentation
• Leading the preparation and review of process validation protocols and reports in collaboration with cross-functional teams
• Facilitating risk assessment activities and promoting quality risk management principles across site operations
• Providing strategic QA support for qualification and validation lifecycle activities
• Overseeing Quality Agreements with customers and external partners, ensuring alignment with regulatory and business requirements
• Supporting regulatory compliance activities and maintaining readiness for inspections and manufacturing license requirements
• Monitoring and trending site Quality KPIs, identifying areas for improvement and driving related action plans
• Acting as a key QA interface with internal stakeholders, promoting a culture of quality, compliance and continuous improvement

What you'll bring to the table

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

• Degree in Scientific disciplines
• Minimum 3 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.