Qa Release Manager Bardi

Qa Release Manager
Bardi
Emilia Romagna, Bardi

3!

Sono gli anni passati dalla creazione della organizzazione del gruppo Novartis Country Quality Italia!

Il DNA del quality assurance è in continua trasformazione e il nostro team Quality è fortemente radicato nel promuovere e garantire un sistema di qualità incentrato nei bisogni dei nostri pazienti, altamente innovativo che promuove e sostiene ogni giorno soluzioni sostenibili e green!

**Your key responsibilities**:

Your responsibilities include, but are not limited to:

- Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are following the Novartis Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.

- Prepare, review and check the batch documentation for correctness, completeness and safely archive the original documents for the prescribed period and plan, conduct and supervise self-Inspection schemes for all sections.

Monitor actions and corrections accordingly.

- Conduct GxP supervising on all sections, conduct QA investigation for noncompliance, follow up the corrective actions.

Archive relative documentations and manage/Approve critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc. )

according to the Quality Agreement and the Novartis Quality Manual.

Ensure investigations are accurately completed.

Ensure all required actions are taken appropriately and in a timely fashion.

- Bring up any issues or instances of instability per the Novartis escalation policy and initiate any market action that is required.

Decide escalation to Senior Management Level and lead Global Quality Assessments and manage filing accordingly as well as ensure that Change requests, are managed according to the Novartis SOPs from receipt, through to the implementation and closure

- Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance and maintain access to regulatory and Pharmaceutical authorities in respect to up-dated GxP.

Provide latest know how in the field of GxP and other quality related fields.

Identify repetitive activities and regulatory areas for which SOPs are required.

Initiate the introduction of SOPs.

- Establish and maintain cross-functional contacts with peer organization and authorities and, follow-up quality related developments in the field of Pharmaceutical products -Support launches of product in close collaboration with BD& L partner and/ or development organization.

- Ensure that all drug products are released to the market in accordance with the registered specifications and with local/international regulations.

**Commitment to Diversity & Inclusion**:

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

**Minimum requirements

**What you'll bring to the role**:

- Proficient Level of English; Italian is not required but a nice to have

- Bachelor degree: Biology, Biotechnology, CTF and similars

- At least 3 years of experience in a similar role, in QA production or in Headquarter acquired in Biotech/Pharma complex environment

- Knowledge of Deviation, Complaints management process, Quality Management system, local/EU GxP regulations, batch quality documental review and batch release process

**Why Novartis?

769 million lives were touched by Novartis medicines in 2020, 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!

**Imagine what you could do at Novartis!

**Division

Novartis Technical Operations

**Business Unit

NTO QUALITY

**Country

Italy

**Work Location

Origgio

**Company/Legal Entity

Novartis Farma IT

**Functional Area

Quality

**Job Type

Full Time

**Employment Type

Regular

**Shift Work

No

**Early Talent

No