Quality & Compliance System Senior Specialist
Chiesi
Overview
In this role you will lead and optimize the Quality Management System to ensure GMP, FDA and EU compliance across the site. You will partner with cross-functional teams to drive quality improvements, manage inspections, training, and documentation, and report on QMS performance. You will enable a culture of quality and continuous improvement, shaping robust processes for materials, manufacturing, and release specifications. This is a chance to contribute to a globally recognized biopharmaceutical group focused on sustainable health outcomes.
Retribuzione / Benefits
- comprehensive healthcare programs
- work-life balance initiatives
- relocation support
- competitive salary
- flexible working arrangements
- remote work options
Responsabilità
- Develop and implement QMS processes, procedures, and documentation to meet quality standards
- Monitor and analyze quality data, identify trends, and drive improvement actions
- Prepare periodic QMS performance reports for management
- Collaborate with production, engineering, procurement and other functions to resolve quality issues
- Investigate quality problems, identify root causes, and implement corrective and preventive actions (CAPA)
- Govern and promote a culture of quality and continuous improvement across the site
- Share best practices and ensure activities comply with company procedures
Requisiti fondamentali
- Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering)
- At least 5 years of pharmaceutical/biopharmaceutical experience in QA, Production, and Process Technology
- Excellent knowledge of EU and FDA pharmaceutical guidelines
- Specialized expertise in GMP compliance improvement processes
- Fluent English (written and spoken)
- Strong teamwork and cross-functional collaboration
- Analytical thinking with ability to assess technical issues and propose shared solutions
- Effective communication and stakeholder management
- QMS development and governance
- Quality data analysis and trend identification
- Root cause analysis and CAPA implementation
Offerta di lavoro pubblicata 1 giorno fa
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