QA Release Specialist

2 settimane fa

Milano, Italia Novartis A tempo pieno

Job Purpose
To support NCQ IM Italy in assuring quality of products distributed in the Italian market and compliance of processes under Pharma CPO responsibility in accordance with existing regulations, company policies, c-GxP.
Major Accountabilities
- To support NCQ IM Italy in maintaining and upgrading Novartis Quality System/SOPs in order to drive compliance thorough all c-GMP related processes.
- To cooperate with NCQ IM Italy to ensure support in quality issues management, according to the Novartis Quality Manual and current c-GxP regulations.
- To ensure that deviations/complaints are timely investigated.
- To ensure that IMPs and commercial products are released to the market in a timely manner and in compliance with, cGMP and regulatory requirements.
- To contribute to assuring priority setting and execution of QA products related activities fully synchronized with the relevant Novartis group business stakeholders.
- To support in maintaining third parties quality oversight in compliance with Novartis Quality Standards.
- To provide QA oversight on IM Medical Dept and TMO GxP related events.
- Back up for quality related topics (e.g. escalation, critical item and recall)

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

What you will bring to the role:

- B.S degree in biology, microbiology, chemistry, Pharmacy or related discipline
- At least 5 years of experience in GxP/pharmaceutical environment
- Knowledge in quality systems and cGxPs
- Knowledge of regulations (EMA, AIFA)
- Experience with external supplier is preferred
- Good communication skills
- Structured working attitude
- Able to work in cross-functional and multi-cultural environment
- Fluency in English is mandatory
- Fulfillment of QP requirements is deemed an asset

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of 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**

No

**Early Talent**

Yes

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