Key Responsibilities
* Certify that each batch of manufactured drugs agrees with the current applicable laws and with drug marketing authorizations or investigational medicinal product dossier.
* Ensure compliance with the rules of hygiene and safety and protection according to Legislative Decree 81/2008.
* Full end-to-end responsibility, ownership and accountability for the whole process from sample receipt to result release (including ownership of the equipment).
* Together 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.
* Writes and/or approves laboratory relevant SOPs and reviews guidelines, Quality Modules, and all analytical work-related documentation.
* Ensures that lab operations are following compliant processes including a high degree of Data Integrity assurance.
* Partners with the Site Quality Head to establish budgets and manages operating expense budget in laboratory area.
* Ensures that all activities are performed according to the local Quality system and SOPs.
* Ensures that appropriate corrective/preventative actions are defined and implemented in due time.
* Supports internal audits and external inspections, according to the Novartis Corporate Quality Manual and supports/participates in NEM cases as required.
* Drives 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.
* Actively works at retaining and developing talents, identifying and responding to their technical and interpersonal development needs.
Essential Requirements
* Scientific Degree (CTF, Pharmacy or Chemistry preferred).
* Previous experience in a leadership role within a laboratory of a pharmaceutical company.
* Knowledge of Quality System and GMP requirements, analytical technology and equipment, incl. qualification and calibration.
* Fluent in Italian and English.
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