QA Release Manager

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

Descrizione del lavoro

Un'importante azienda biopharma sta cercando un professionista esperto in Quality Assurance a Origgio. Il candidato dovrà gestire standard di qualità riguardanti la manipolazione e produzione di prodotti farmaceutici. Richiesta laurea in Biologia ed esperienza di almeno 3 anni nel settore. Offriamo un ambiente di lavoro innovativo e inclusivo, focalizzato sul miglioramento continuo e sulla compliance normativa.

Servizi

Ambiente di lavoro inclusivo

Opportunità di crescita professionale

Competenze

• Almeno 3 anni di esperienza nella qualità in ambienti biotech/farma.
• Conoscenza delle normative GxP locali/UE.
• Capacità di preparare e rivedere la documentazione di batch.

Mansioni

• Garantire conformità alle normative e linee guida di qualità.
• Condurre supervisione GxP e gestire problemi di non conformità.
• Guidare miglioramenti nei processi e nella qualità del prodotto.

Conoscenze

Conoscenza del sistema di gestione qualità

Gestione delle deviazioni e dei reclami

Competenze di comunicazione in inglese

Formazione

Laurea in Biologia, Biotecnologia o simili

Strumenti

Sistemi di gestione qualità

Descrizione del lavoro

3! Sono gli anni passati dalla creazione dell'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 soluzioni sostenibili e green!

Your key responsibilities

Your responsibilities include, but are not limited to :

1. Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical/pharmaceutical products follow the Novartis Quality Manual, the effective Quality Agreement, meet relevant GxP regulatory requirements, and are conducted according to local SOPs.
2. Prepare, review, and check batch documentation for correctness and completeness; safely archive original documents; plan, conduct, and supervise self-inspection schemes for all sections; monitor actions and corrections accordingly.
3. Conduct GxP supervision across all sections; investigate non-compliance issues; follow up on corrective actions; archive relevant documentation; manage and approve critical quality issues such as deviations, complaints, recalls, counterfeits, tampering, and stability failures, ensuring investigations are completed accurately and actions are timely.
4. Report issues or instability per the Novartis escalation policy; initiate market actions if required; escalate to senior management; lead global quality assessments; manage filing; ensure change requests are managed according to SOPs from receipt through implementation and closure.
5. Assess quality trends; drive continuous improvement in processes and product quality; maintain regulatory compliance; provide expertise in GxP and related fields; identify activities requiring SOPs and initiate their introduction.
6. Establish and maintain cross-functional contacts; follow quality developments in pharmaceutical products; support product launches in collaboration with business development and/or development teams.
7. Ensure all drug products are released in accordance with specifications and regulations.
8. Commitment to Diversity & Inclusion: Novartis aims to build an inclusive, diverse work environment reflective of the patients and communities served.

Minimum requirements

What you’ll bring to the role

• Proficient in English; Italian is a plus.
• Bachelor's degree in Biology, Biotechnology, CTF, or similar fields.
• At least 3 years of experience in QA production or headquarters in biotech/pharma environments.
• Knowledge of deviation and complaints management, quality management systems, local/EU GxP regulations, batch documentation review, and batch release processes.

Why Novartis?

In 2020, Novartis medicines touched 769 million lives. We believe in innovation at the intersection of science and digital technology, fostering an inclusive environment that inspires new ways of working. Our culture is built on integrity, curiosity, and flexibility, empowering us to tackle tough medical challenges. The greatest risk is 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 and Early Talent opportunities are also available.