QA Compliance Team Leader

Novartis Farmacéutica; Torre Annunziata; In loco; EUR 50.000 - 85.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a QA Compliance Team Leader in Torre Annunziata, Italy. The role involves ensuring compliance with GxP standards and supporting audits, requiring expertise in Quality Assurance and fluency in Italian and English. Join a community dedicated to improving patients' lives through innovative science.

Competenze

• Previous experience in a Quality Assurance department within a pharma manufacturing environment.
• Fluent in Italian and English.

Mansioni

• Planning and supporting PQR/APQR activities.
• Support site qualification and validation activities.
• Implementation of Quality Systems and documentation management.
• Preparation and coordination of CAPA.
• Audit and inspection preparation and support.

Conoscenze

Quality Systems

GxP Compliance

Audit Preparation

Documentation Management

Inspection Support

Italian

English

Descrizione del lavoro

The QA Compliance Team Leader supports effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators).
Supports the preparation and management of external and corporate audits and Health Authority inspections.

About the Role

Major accountabilities:

• Planning and supporting PQR/APQR activities.
• Support site qualification and validation activities (planning, advising, review).
• Implementation of Quality Systems (incl. documentation management).
• Preparation/support and coordination of CAPA/follow-up.
• Audit and inspection preparation and support.
• Change control review/approval.
• Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc.).
• Ensure process quality assurance according to regulations.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Previous experience in a Quality Assurance department within a pharma manufacturing environment.
• Fluent in Italian and English.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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