Senior Quality Specialist
1 giorno fa
Job Description
For Quality Analytics, we are seeking a talented Senior Quality Specialist to support the implementation, execution and management of the Corporate Quality System in Italy. The ideal candidate will have a strong understanding of GxP regulations and quality systems, with the ability to function independently and in a matrix environment.
Key Responsibilities
• Manage and maintain the local Quality Management System (QMS) ensuring alignment with company and applicable health authority requirements.
• Ensure quality regulatory surveillance, conducting impact analysis and sharing new or emerging GxP and regulatory changes impacting the Country.
• Support in maintaining the affiliate in a state of control and inspection readiness, facilitating local audits and inspections working with corporate groups.
• Monitor GxP compliance to regulations and Alexion's procedures and communicating performance, CAPAs and action plans.
Requirements
• At least 4-year experience in GxP regulated environment and/or in quality compliance roles for GxP activities in pharmaceutical industry.
• Previous experience in biotech industry will be a plus.
• Good understanding of GxP regulations, guidance principles and processes, with specific focus on Good Distribution Practices.
• Ability to pragmatically interpret GxP regulations, laws and guidelines with ability to share experience.
• Strong written and verbal communication and organizational skills.
• Ability to work independently and collaborate effectively with cross-functional colleagues at all levels of the organization.
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