QA Compliance Team Leader

Novartis; Messina; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Messina is seeking a QA Compliance Team Leader to support GxP Compliance and manage audit activities. The role requires fluency in Italian and English, along with prior experience in Quality Assurance in a pharmaceutical setting. Key responsibilities include planning audits, supporting site qualification, and ensuring compliance with quality standards.

Competenze

• Previous experience in Quality Assurance within a pharmaceutical environment.
• Knowledge of GxP industry standards.
• Process optimization and quality assurance expertise.

Mansioni

• Plan and support PQR/APQR activities.
• Manage external audits and inspections.
• Implement Quality Systems and manage documentation.

Conoscenze

Quality Assurance

GMP procedures knowledge

Fluent in Italian

Fluent in English

Strumenti

Hyperion

ABAP

Descrizione del lavoro

The QA Compliance Team Leader supports effective GxP Compliance and Audit activities to ensure business areas adhere to the Novartis Quality Manual, Policies, and all relevant GxP legal and regulatory requirements. This includes monitoring through internal audits, KPIs, and KQIs.

Responsibilities include preparing for and managing external and corporate audits and Health Authority inspections.

Major accountabilities :

• Planning and supporting PQR / APQR activities.
• Supporting site qualification and validation activities, including planning, advising, and review.
• Implementing Quality Systems, including documentation management.
• Managing supplier activities, including oversight of agreements and audits.
• Preparing, supporting, and coordinating CAPA processes and follow-up.
• Supporting audit and inspection preparations.
• Reviewing and approving change controls.
• Ensuring local DI and eCompliance oversight, including training, inspections, planning, risk identification, etc.
• Ensuring process quality assurance in compliance with regulations.
• Reporting technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.

Minimum requirements :

Previous experience in a Quality Assurance department within a pharmaceutical manufacturing environment.

Fluency in Italian and English.

Knowledge of GMP procedures, GxP industry standards, process optimization, quality assurance, and related technological expertise.

Key skills include familiarity with Hyperion, Acquisition, Asset, ABAP, Basic, ActiveX, among others.

Employment Type : Full-Time

Experience : Years (please specify)

Vacancy : 1

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