QA Systems Specialist

Grünenthal Group; Origgio; On-site; EUR 37,000 - 43,000; Full time

Job summary

Grünenthal Group in Italy is seeking a dedicated Quality Assurance professional for our Manufacturing & Global Operations team. The role focuses on coordinating Change Control, supporting GMP-compliant training, and ensuring timely product quality reviews.

You will lead self-inspections, help develop validation protocols, monitor quality KPIs, and act as QA interface with internal stakeholders, driving continuous improvement.

Qualifications

• Degree in Scientific disciplines.
• Minimum 3 years of experience in Quality Assurance within the pharmaceutical sector.
• Knowledge of GMP and regulatory requirements.
• Competency in communication and interfaces management.
• Fluent English.

Responsibilities

• Coordinate Change Control processes, ensuring timely assessment, implementation and effectiveness verification.
• Support the development and execution of site training plans to ensure GMP/compliance.
• Coordinate the preparation, review and approval of Product Quality Reviews (PQRs) and identify trends.
• Plan and lead self-inspections, facilitate CAPA definition and monitoring.
• Provide QA oversight for Master Batch Records and GMP documentation.
• Lead the preparation and review of validation protocols and reports with cross-functional teams.
• Promote quality risk management across site operations and support regulatory readiness.
• Oversee Quality Agreements with customers and partners to meet regulatory requirements.

Skills

Fluent English

Quality Assurance

Education

Degree in Scientific disciplines

Job description

Pay Range (full time): EUR 37.000 - 43.000

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

• 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

• 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
• Fluent English

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.