QA Release Specialist

Novartis; Milano; In loco; EUR 50.000 - 75.000; Tempo pieno

Descrizione del lavoro

A prominent pharmaceutical company is seeking a Quality Assurance professional to support compliance and quality system upgrades in Milano. The ideal candidate will have a B.S. degree, extensive experience in the GxP environment, and strong communication skills. The role emphasizes collaboration, timely investigations, and maintaining quality oversight of processes. Join a team dedicated to improving lives through innovative medical solutions.

Competenze

• At least 5 years of experience in GxP/pharmaceutical environment.
• Knowledge of quality systems and cGxPs.
• Understanding of regulations (EMA, AIFA).

Mansioni

• Support maintaining and upgrading the Quality System.
• Manage quality issues according to the Novartis Quality Manual.
• Ensure timely investigation of deviations and complaints.

Conoscenze

Strong communication skills

Structured working attitude

Ability to work effectively in cross-functional environments

Fluency in English

Formazione

B.S. degree in biology, microbiology, chemistry, pharmacy, or related discipline

Descrizione del lavoro

Job Purpose

To support NCQ IM Italy in assuring the quality of products distributed in the Italian market and ensuring compliance of processes under Pharma CPO responsibility in accordance with existing regulations, company policies, and c-GxP standards.

Major Accountabilities

1. Support NCQ IM Italy in maintaining and upgrading the Novartis Quality System / SOPs to ensure compliance across all c-GMP related processes.
2. Collaborate with NCQ IM Italy to manage quality issues according to the Novartis Quality Manual and current c-GxP regulations.
3. Ensure timely investigation of deviations and complaints.
4. Guarantee that IMPs and commercial products are released to the market promptly and in compliance with cGMP and regulatory requirements.
5. Contribute to setting priorities and executing QA activities aligned with relevant Novartis group business stakeholders.
6. Assist in maintaining quality oversight of third parties in compliance with Novartis Quality Standards.
7. Provide QA oversight on IM Medical Department and TMO GxP-related events.
8. Serve as backup for quality-related topics such as escalation, critical items, and recalls.
9. Demonstrate commitment to Diversity & Inclusion by fostering an inclusive work environment.

Minimum requirements

• B.S. degree in biology, microbiology, chemistry, pharmacy, or a related discipline.
• At least 5 years of experience in GxP/pharmaceutical environment.
• Knowledge of quality systems and cGxPs.
• Understanding of regulations (EMA, AIFA).
• Experience with external suppliers is preferred.
• Strong communication skills.
• Structured working attitude.
• Ability to work effectively in cross-functional and multicultural environments.
• Fluency in English is mandatory.
• Fulfillment of QP requirements is considered an asset.

Why Novartis?

In 2021, Novartis medicines touched 766 million lives. We are committed to improving and extending people’s lives through innovative solutions at the intersection of medical science and digital innovation. We foster a diverse, equitable, and inclusive environment that inspires new ways of working. Our culture is built on integrity, curiosity, and flexibility, empowering us to tackle the world's toughest medical challenges with courage and collaboration. Because the greatest risk in life is never trying.

Imagine what you could do here at Novartis!

• Division: Operations
• Business Unit: QUALITY
• Country: Italy
• Work Location: Milano
• Company / Legal Entity: Novartis Farma IT
• Functional Area: Quality
• Job Type: Full Time
• Employment Type: Regular
• Shift Work
• Early Talent