Quality Assurance Supervisor

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/77udc7

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. /ppProvide 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. /ph3The Role /h3ulliEnsuring general EU GMP/GDP compliance as well as compliance to local regulations. /liliLiaising with Corporate office/BRS/Warehouse for batch related documents, including importing documentation, Data Loggers, CMR, etc. /liliReview and evaluate batch release documents for local release with the warehouse /liliCoordination of BRC/CoA Activities with QA Corporate /liliSupport managing and reporting Rapid alert activities and GMP non-compliance alert (AIFA notifications) /liliMaintain local QMS in accordance with Corporate QA requirements /liliManage Change Controls, Deviations, CAPA and Risk Management /liliMastering Recalls, returned goods, Market complaints and Medical Enquiries, both at Corporate level and at customers’ level /liliMaintain in maintenance of ISO 9001 and ISO 14001 certification. /liliQA 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. /liliPlanning and conducting Self-inspections /liliCoordinate with contract warehouse for PQR preparation, review maintenance related to Repacking activities. /liliSupport to Tender Dept. for qualitative related documentation. /liliMaintenance of RA/QA internal databases and product master data /liliDTF 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...) /liliQuality Technical Agreement activities /liliEnsure that sampling activities for import batches from non-EU countries are performed in compliance with internal GMP / SOP from the warehouse /liliEvaluate and ensure the integrity of import shipments based on the documentation shared by the warehouse /liliRetrieval of data loggers and collection of temperature excursions for evaluation and approval. /liliSupport 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. /liliSupport for the import process from EU and non-EU countries, Customs clearance and invoicing process (Direct Shipment) /liliSupport local affiliate in SOP creation, update and management /li /ulh3The Person /h3ulliPrevious professional experience on similar position in QA Department in pharmaceutical company or national competent authority could be a plus /liliKnowledge of general EU GMP and GDP requirements and local laws and requirements such as D. Lgs. 219/2006. /liliExperience of conducting quality based investigations and root cause analysis /liliUnderstanding and experience of Product Quality Review requirements, Change Control, CAPAs, Deviation management and validation/qualification activities /liliCommunication skills with a strong focus of collaboration /liliExcellent knowledge of MS Office, especially Excel /liliFluent English (B2 is minimum) /li /ulh3Clearly define any essential or desirable /h3ulliQualifications: pharmacy, biotechnology, biology, chemistry or similar. /liliCertifications or accreditations: auditor qualification could be a plus /li /ulh3The Rewards /h3ulliBase annual salary between 41.000 Eur and 45.000 Eur based on experience and interview outcome /li /ul /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/77udc7