GxP Country Quality Senior Specialist (Italy) Reports to: Director, Italy Regulatory Affairs and Quality
Location: Office-based, Milan, Italy
Position Summary The GxP Country Quality Senior Specialist will be supporting the implementation, execution and management of the Corporate Quality System in Italy ensuring that the pharmaceutical operations remain compliant with local requirements and corporate policies.
The candidate will have good experience in GxP's, quality systems as well as the ability to function independently and in a matrix environment.
Principal Responsibilities This position contains tasks related to quality. Tasks may change over time across and within the respective areas depending on Alexion business needs.
In coordination with the GxP Country Quality colleagues and related peers within the Global Quality organization, the GxP Country Quality Senior Specialist will support the local Country Quality to ensure the roll out and on-going compliance to Alexion's global quality systems, and associated procedures and standards at the site level:
Managing and maintaining the local Quality Management System (QMS) ensuring alignment with company and applicable health authority requirementsEnsuring quality regulatory surveillance, conducting impact analysis and sharing new or emerging GxP and regulatory changes impacting the CountrySupport in maintaining the affiliate in a state of control and inspection readiness, facilitating local audits and inspections working with corporate groupsMonitoring GxP compliance to regulations and Alexion's procedures and communicating performance, CAPAs and action plansProvide Quality Expertise and support the liaison between the local teams and global stakeholders fostering a proactive quality and compliance culture.Managing the follow-up and supporting staff in the drafting of deviations, CAPAs, change control...Support in quality management reviews (monitoring of performance indicators, trend analysis…)Supporting specific projects related to quality requirements or global project deploymentDriving continuous improvement/remediation plans identified through e.g. Corporate audits and CAPA monitoring reviews etc.Support in the management of GxP related tasks, but not limited to:DeviationsChange ControlCAPAProduct Complaints/Technical RequestsSupplier and customer qualificationRecallRegulatory Authority InteractionSelf-inspectionTrainingDocumentationSubcontracted activitiesQuality Management reviewQuality Risk ManagementDrafting and updating SOPs under quality responsibilityCan be assigned as Lead to specific projects.Acting as backup for Senior Manager, Country Quality GxP Compliance during absence or unavailability, with specific focus on GDP activitiesQualifications 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 plusGood 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 shareExperience in Risk Management Plan implementation activities.Strong written and verbal communication and organizational skillsAbility to work independently and collaborate effectively with cross-functional colleagues (e.g. regulatory, drug safety, medical) at all levels of the organization.Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs.Ability to multi-task and prioritize work.Fluency in English (speaking, reading, and writing)Knowledge in QMS activities and Electronic Quality Systems.Proficiency in Microsoft applications (Excel, Word, PowerPoint)Education Bachelor's degree or equivalent, preferably in life sciences (pharmacy, biology, etc.).Master in Quality will be a plus.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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