QMS Lead, GMP & Compliance

Chiesi Group; Parma; In loco; EUR 46.000 - 57.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Flexible benefits programme

Relocation support

Remote work options

Descrizione del lavoro

Chiesi Group in Parma seeks a Quality & Compliance System Senior Specialist to lead inspections, training, documentation, and site compliance, driving quality KPIs and master document releases across raw materials, materials, and finished product release specifications.

The role focuses on continuous QMS improvement, ensuring GMP, FDA, and EU regulatory compliance while collaborating with production, engineering, and procurement teams for process enhancements and issue resolution.

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

• Developing and implementing Quality Management Systems (QMS): creating and updating procedures, processes, and documentation to meet quality standards.
• Monitoring and analyzing quality data: tracking quality metrics, identifying trends, and pinpointing areas for improvement.
• Prepare and submit periodic reports on QMS performance to company management.
• Working with cross-functional teams: collaborate with other departments to resolve quality issues and improve processes.
• Investigating quality issues: analyzing root causes and developing corrective and preventative actions.
• Quality system governance: fostering a culture of quality and ongoing improvement.
• Promote continuous improvements and share best practices, ensuring compliant quality activities.

Conoscenze

GMP compliance

Quality Assurance

Documentation

Data analysis

Fluent English

Formazione

Degree in scientific subjects

Descrizione del lavoro

Chiesi Group in Parma seeks a Quality & Compliance System Senior Specialist to lead inspections, training, documentation, and site compliance, driving quality KPIs and master document releases across raw materials, materials, and finished product release specifications.

The role focuses on continuous QMS improvement, ensuring GMP, FDA, and EU regulatory compliance while collaborating with production, engineering, and procurement teams for process enhancements and issue resolution.