QA Systems Lead: GMP Quality & Compliance

Gr?nenthal GmbH; Lombardia; Hybrid; EUR 37,000 - 43,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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

Education

Degree in Scientific disciplines

Job description

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.