Quality Assurance Specialist

hace 2 semanas

Santiago de Chile Novartis A tiempo completo

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.
- Your main responsibilities:
- Ensure that processes are conducted in full compliance with the GxP and the Novartis Quality. Support with regards to GxP relevant documents, processes and systems
- Monitoring and reporting of numbers and maintaining of matrices
- Training Management, Escalation Management, Risk Management. Provide functional expertise in area of responsibility & represent QA in initiative and act as a interface between departments and within the QA. System administration -Contributes to an improvement of current processes and/or to an implementation of modified processes.
- Develop and improve GxP processes to meet internal and external guidelines -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
- Distribution of marketing samples (where applicable)
- Manage and conduct review of batch records documents and release products to market/artwork materials in compliance with registered specifications and GMPs. Manages quality issues (general deviations, temperature excursions, complaints, recalls, counterfeits, etc.) according to the QAA and Novartis Quality Manual.
- Ensure investigations are correctly executed. Ensures that all aspects of the handling, release, and distribution of pharmaceutical products are in compliance with the Novartis Quality Manual and Policies. Handles change control activities, artwork reviews and approvals, returns, complaints. Manages progress of audits in AQWA as QARP (and/or FURP if necessary).
- Manages QAAs by ensuring valid Quality Agreements are in place and are in line with the global templates, clearly defining GMP roles and responsibilities between Novartis and external suppliers. Performs third party oversight for artwork printing, repackaging and warehouse & distribution activities.

**Commitment to Diversity & Inclusion**:

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

**Minimum requirements**
- Pharmacist Degree validated in Chile.
- 3-5years experience in Pharma/Manufacturing sector in analytical lab in a GMP environment/equivalent
- Spanish Knowledge of GMP
- Knowledge of CAPA
- Management of Quality Audit, Quality Change Control, Good Documentation Practice,

Why consider 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
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
**Division**
- Novartis Technical Operations

**Business Unit**
- QUALITY

**Country**
- Chile

**Work Location**
- Región Metropolitana

**Company/Legal Entity**
- Novartis Chile S.A

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- Yes

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