The QA Supervisor will have To ensure that current and future EU GMDP requirements are met and that an effective and robust Pharmaceutical Quality System is maintained.
Provide direct support in the management/maintenance of the day to day aspects of the QA. To work with other departments to ensure a strong QA culture throughout the business and providing guidance as required.
The Role Ensuring general EU GMP/GDP compliance as well as compliance to local regulations.
Liaising with Corporate office/BRS/Warehouse for batch related documents, including importing documentation, Data Loggers, CMR, etc.
Review and evaluate batch release documents for local release with the warehouse
Coordination of BRC/CoA Activities with QA Corporate
Support managing and reporting Rapid alert activities and GMP non-compliance alert (AIFA notifications)
Maintain local QMS in accordance with Corporate QA requirements
Manage Change Controls, Deviations, CAPA and Risk Management
Mastering Recalls, returned goods, Market complaints and Medical Enquiries, both at Corporate level and at customers' level
Maintain in maintenance of ISO **** and ISO ***** certification.
QA training: coordinating with all departments and new comers for training and maintaining the training records for GMP/GDP/QMS. Maintain Qedge TMS system for all local trainings.
Planning and conducting Self-inspections
Coordinate with contract warehouse for PQR preparation, review & maintenance related to Repacking activities.
Support to Tender Dept. for qualitative related documentation.
Maintenance of RA/QA internal databases and product master data
DTF process and Importation activities due to AIFA shortages and commercial opportunities,



including Dossier drafting for AIFA submission (i.e Product Identity Declaration from releasing QP, Import authorization request...)
Quality Technical Agreement activities
Ensure that sampling activities for import batches from non-EU countries are performed in compliance with internal GMP / SOP from the warehouse
Evaluate and ensure the integrity of import shipments based on the documentation shared by the warehouse
Retrieval of data loggers and collection of temperature excursions for evaluation and approval.
Support on maintenance and renewal of the Narcotics / Narcotics Authorization Decree: ensure that all Narcotics licenses are applied and available for import / export shipments in order to comply with Italian law.
Support for the import process from EU and non-EU countries, Customs clearance and invoicing process (Direct Shipment)
Support local affiliate in SOP creation, update and management
The Person Previous professional experience on similar position in QA Department in pharmaceutical company or national competent authority could be a plus
Knowledge of general EU GMP and GDP requirements and local laws and requirements such as D. Lgs. ********.
Experience of conducting quality based investigations and root cause analysis
Understanding and experience of Product Quality Review requirements, Change Control, CAPAs, Deviation management and validation/qualification activities
Communication skills with a strong focus of collaboration
Excellent knowledge of MS Office, especially Excel
Fluent English (B2 is minimum)
Clearly define any essential or desirable Qualifications: pharmacy, biotechnology, biology, chemistry or similar.
Certifications or accreditations: auditor qualification could be a plus
The Rewards Base annual salary between ****** Eur and ****** Eur based on experience and interview outcome
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📌 Quality Assurance Supervisor (Bardi)
🏢 Altro
📍 Bardi