Quality Control Head

Novartis Italia; Saluggia; In loco; EUR 45.000 - 80.000; Tempo pieno

Descrizione del lavoro

Un'azienda leader nel settore farmaceutico cerca un Responsabile del Controllo Qualità per guidare il team di Saluggia. In questa posizione strategica, sarai responsabile della conformità e della qualità, assicurando che tutte le operazioni di laboratorio soddisfino gli standard normativi e di eccellenza. Collaborerai con il team di leadership per sviluppare strategie e garantire che il laboratorio operi in modo efficiente e conforme. Se sei un leader esperto con una passione per la qualità e la sicurezza, questa è un'opportunità imperdibile per contribuire a un ambiente di lavoro inclusivo e innovativo.

Competenze

• Esperienza pregressa in un ruolo di leadership in un laboratorio farmaceutico.
• Conoscenza dei requisiti del sistema di qualità e delle normative GMP.

Mansioni

• Responsabilità completa dal ricevimento del campione al rilascio dei risultati.
• Scrivere e approvare SOP rilevanti per il laboratorio e documentazione analitica.

Conoscenze

Leadership

Quality Control

Data Integrity

Analytical Technology

GMP Requirements

Problem Solving

Team Development

Formazione

Scientific Degree (CTF, Pharmacy or Chemistry preferred)

Strumenti

Laboratory Equipment

Descrizione del lavoro

Summary

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.

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.

About The Role

Key responsibilities:

1. Certify that each batch of manufactured drugs agrees with the current applicable laws and with drug marketing authorizations or investigational medicinal product dossier.
2. Ensure compliance with the rules of hygiene and safety and protection according to Legislative Decree 81/2008.
3. Full end-to-end responsibility, ownership and accountability for the whole process from sample receipt to result release (including ownership of the equipment).
4. 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.
5. Writes and/or approves laboratory relevant SOPs and reviews guidelines, Quality Modules, and all analytical work-related documentation.
6. Ensures that lab operations are following a compliant processes including a high degree of Data Integrity assurance.
7. Partners with the Site Quality Head to establish budgets and manages operating expense budget in laboratory area.
8. Ensures that all activities are performed according to the local Quality system and SOPs.
9. Ensures that appropriate corrective / preventative actions are defined and implemented in due time.
10. Supports internal audits and external inspections, according to the Novartis Corporate Quality Manual and supports / participates in NEM cases as required.
11. 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.
12. Actively works at retaining and developing talents, identifying and responding to their technical and interpersonal development needs.

Essential Requirements

1. Scientific Degree (CTF, Pharmacy or Chemistry preferred).
2. Previous experience in a leadership role within a laboratory of a pharmaceutical company.
3. Knowledge of Quality System and GMP requirements, analytical technology and equipment, incl. qualification and calibration.
4. Fluent in Italian and English.

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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