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Quality control head

Saluggia
Novartis Italia
Pubblicato il Pubblicato 6h fa
Descrizione

PstrongSummary /strongbr/br/The Quality Control Head leads Saluggia Quality Control (QC) team by developing and executing strategic plans, providing direction for organizational structure, GMP and safety strategy, lean and continuous improvement initiatives and people training and development.br/br/The QC Head is responsible for ensuring that the lab unit meets all agreed-upon objectives and Key Performance Indicators (KPI), specifically related to Compliance and Quality-related topics. /ppstrongAbout The Role /strongbr/br/strongKey responsibilities: /strongbr/br/ /polliCertify that each batch of manufactured drugs agrees with the current applicable laws and with drug marketing authorizations or investigational medicinal product dossier. /liliEnsure compliance with the rules of hygiene and safety and protection according to Legislative Decree 81/2008. /liliFull end-to-end responsibility, ownership and accountability for the whole process from sample receipt to result release (including ownership of the equipment). /liliTogether with the Site Quality Head and the Leadership Team, QC Head formulates strategies and makes decisions which ensure the efficient and compliant operations of Saluggia Site. /liliWrites and/or approves laboratory relevant SOPs and reviews guidelines, Quality Modules, and all analytical work-related documentation. /liliEnsures that lab operations are following a compliant processes including a high degree of Data Integrity assurance. /liliPartners with the Site Quality Head to establish budgets and manages operating expense budget in laboratory area. /liliEnsures that all activities are performed according to the local Quality system and SOPs. /liliEnsures that appropriate corrective / preventative actions are defined and implemented in due time. /liliSupports internal audits and external inspections, according to the Novartis Corporate Quality Manual and supports / participates in NEM cases as required. /liliDrives lab objectives by providing leadership, direction and support to the team members and ensuring that they are adequately qualified and trained to achieve a high level of competence and are motivated to excel. /liliActively works at retaining and developing talents, identifying and responding to their technical and interpersonal development needs. /li /olpstrongEssential Requirements /strongbr/br/ /polliScientific Degree (CTF, Pharmacy or Chemistry preferred). /liliPrevious experience in a leadership role within a laboratory of a pharmaceutical company. /liliKnowledge of Quality System and GMP requirements, analytical technology and equipment, incl. qualification and calibration. /liliFluent in Italian and English. /li /olpstrongCommitment to Diversity and Inclusion /strong: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. /ppstrongBenefits and Rewards: /strong Read our handbook to learn about all the ways we’ll help you thrive personally and professionally. /p #J-18808-Ljbffr

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