Quality Assurance Supervisor

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/Co A 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 9001 and ISO 14001 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. 219/2006.
• 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 salry between 41.000 EUR and 45.000 EUR based on experience and interview outcome
• Ticket restaurant
• Annual bonus
• Training and development
• Flexibility

All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

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