Quality & Compliance System Senior Specialist
5 giorni fa
Who we are looking for Main Responsibilities Developing and Implementing Quality Management Systems (QMS): this includes 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.Preparing and submitting periodic reports on the performance of the quality management system to company management.Conducting Audits and Inspections: Ensuring compliance with established quality systems through regular audits and inspections of processes and products.Planning, coordinating, and conducting internal and external audits to verify compliance with GMP, ISO, and corporate regulatory requirements.Ensuring that any non-conformities identified are resolved promptly.Defining and monitoring the implementation of corrective and preventive actions (CAPA) following audits with periodic follow-ups.Maintaining and updating audit documentation, including self-audit plans and reports.Preparating pre-inspection documentation and site GMP documentation required for inspection and regulatory purposes Working with Cross-Functional Teams: collaborating with other departments (e.g., production, engineering, procurement) to resolve quality issues and improve processes.Investigating Quality Issues: analyzing root causes of quality problems and developing corrective and preventative action plans.Experience Required At least 5 years of experience in manufacturing sites within the pharmaceutical and biopharmaceutical sector, specifically in Quality Assurance, Production, and Process Technology departments.Education Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering).Languages Fluent English (both written and spoken).Technical Skills Excellent knowledge of pharmaceutical guidelines (EU and FDA regulations).Ability to establish strategies for managing multiple projects efficiently and effectively.Specialized expertise in GMP compliance improvement processes.Strong teamworking skills, contributing positively and constructively to achieving goals.Capacity to analyze technical issues and find shared solutions, evaluating related risks.Soft Skills Attention to details Problem solving Team working Planning and organizational skills What we offer You would join a dynamic, fast-growing, challenging and friendly environment.In Chiesi we firmly believe that our people are our most valuable asset , that is why we invest in continuous training, learning and development.Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.We want our people to come to work happy every day , and we know how important it is to find the right work-life balance in order to be able to give our best.That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
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