Quality & Compliance Systems Senior — GMP & QMS Expert

Chiesi Farmaceutici S.p.A.; Parma; Ibrido; EUR 46.000 - 57.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Flexible benefits programme

Relocation support

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. in Parma, IT, is seeking a Quality & Compliance System Senior Specialist to manage inspections, documentation, site compliance, and quality KPIs within the Quality Operations Italy, Parma Site.

The role focuses on sustaining QMS and ensuring GMP, FDA, and EU regulation adherence. The ideal candidate will lead QMS-related projects, collaborate with production and engineering, and drive continual improvements.

Competenze

• Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering).
• At least 5 years of experience in manufacturing sites within the pharmaceutical and biopharmaceutical sector, specifically in Quality Assurance, Production, and Process Technology departments.
• Excellent knowledge of pharmaceutical guidelines (EU and FDA regulations).
• Specialized expertise in GMP compliance improvement processes.
• Fluent English (both written and spoken).

Mansioni

• Managing inspections, training, documentation, site compliance, quality KPIs, and the preparation of master documents such as raw materials, materials, and finished product release specifications.
• Managing and continuous improvement of the Quality Management System (QMS), with a focus on QMS-related projects.
• Developing and implementing Quality Management Systems (QMS) procedures, processes, and documentation to meet quality standards.
• Monitoring and analyzing quality data, tracking quality metrics, identifying trends, and pinpointing areas for improvement.
• Preparing and submitting periodic reports on QMS performance to company management.
• Working with cross-functional teams to resolve quality issues and improve processes.
• Investigating quality issues, analyzing root causes, and developing corrective and preventive action plans.
• Quality system governance and fostering a culture of quality and continuous improvement.
• Promoting continuous improvements and sharing best practices to ensure compliance with procedures.

Conoscenze

Fluent English

Formazione

Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering)

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. in Parma, IT, is seeking a Quality & Compliance System Senior Specialist to manage inspections, documentation, site compliance, and quality KPIs within the Quality Operations Italy, Parma Site.

The role focuses on sustaining QMS and ensuring GMP, FDA, and EU regulation adherence. The ideal candidate will lead QMS-related projects, collaborate with production and engineering, and drive continual improvements.