Quality Assurance Supervisor

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/790grj

ppThe 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. /p pProvide 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. /p h3The Role /h3 ul liEnsuring general EU GMP/GDP compliance as well as compliance to local regulations. /li liLiaising with Corporate office/BRS/Warehouse for batch related documents, including importing documentation, Data Loggers, CMR, etc. /li liReview and evaluate batch release documents for local release with the warehouse. /li liCoordination of BRC/CoA Activities with QA Corporate. /li liSupport managing and reporting Rapid alert activities and GMP non‑compliance alert (AIFA notifications). /li liMaintain local QMS in accordance with Corporate QA requirements. /li liManage Change Controls, Deviations, CAPA and Risk Management. /li liMastering Recalls, returned goods, Market complaints and Medical Enquiries, both at Corporate level and at customers’ level. /li liMaintain in maintenance of ISO 9001 and ISO 14001 certification. /li liQA 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. /li liPlanning and conducting Self‑inspections. /li liCoordinate with contract warehouse for PQR preparation, review maintenance related to Repacking activities. /li liSupport to Tender Dept. for qualitative related documentation. /li liMaintenance of RA/QA internal databases and product master data. /li liDTF 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...). /li liQuality Technical Agreement activities.



/li liEnsure that sampling activities for import batches from non‑EU countries are performed in compliance with internal GMP / SOP from the warehouse. /li liEvaluate and ensure the integrity of import shipments based on the documentation shared by the warehouse. /li liRetrieval of data loggers and collection of temperature excursions for evaluation and approval. /li liSupport 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. /li liSupport for the import process from EU and non‑EU countries, Customs clearance and invoicing process (Direct Shipment). /li liSupport local affiliate in SOP creation, update and management. /li /ul h3The Person /h3 ul liPrevious professional experience on similar position in QA Department in pharmaceutical company or national competent authority could be a plus. /li liKnowledge of general EU GMP and GDP requirements and local laws and requirements such as D. Lgs. 219/2006. /li liExperience of conducting quality based investigations and root cause analysis. /li liUnderstanding and experience of Product Quality Review requirements, Change Control, CAPAs, Deviation management and validation/qualification activities. /li liCommunication skills with a strong focus of collaboration. /li liExcellent knowledge of MS Office, especially Excel. /li liFluent English (B2 is minimum). /li liQualifications: pharmacy, biotechnology, biology, chemistry or similar. /li liCertifications or accreditations: auditor qualification could be a plus. /li /ul h3The Rewards /h3 ul liBase annual salry between 41.000 EUR and 45.000 EUR based on experience and interview outcome. /li liTicket restaurant. /li liAnnual premio. /li liTraining and development. /li liFlexibility. /li /ul pAll applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability. /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/790grj