Quality Control Associate

329133BR
Oct 05, 2021
Chile

Job Description

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 1 billion people globally and we are finding innovative ways to expand access to our latest treatments. About 125 000 people of more than 140 nationalities work at Novartis around the world.

We are Novartis Country Quality, collaborating regionally and locally with the areas of Regulatory Affairs, Medical, Compliance, Commercial, Supply Chain, etc. If you are curious, courageous and collaborative then this is the right place for you! We need people who have the ability to work within teams, highly organized, with great communcation skills and high motivation to learn and accept new challenges.

Your responsibilities:
Your responsibilities include, but are not limited to:
• QA SPOC with third parties (third party logistics and QC labs) – for local testing technical support and requests, OOX investigations, follow up of CAPA plans and escalations to ensure adequate tracking and on time completion.
• Submission of QC retesting waivers to HA when applicable.
• Perform statistical analysis of retesting results and ensures compliance to all relevant regulations.
• Manage reference standards and samples for AMT and routine testing.
• Ensures the timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting.
• Assists in Health Authority inspections and internal audits by supplying information and documentation in a timely manner
• Support and track the implementation and maintenance of the local Quality system in in accordance with the Novartis Quality Manual
• Manages processes and systems for all GxP Quality Assurance e.g. Change control, Training Management, Escalation Management, Risk Management.
• Ensures that processes are conducted in full compliance with the GxP and the Novartis Quality and supports Compliance review of projects and inspection readiness and management
• Prepare and review GxP documentation; assists in the release of GxP documentation, filing and archiving of GxP documentation

What you’ll bring to the role
• Spanish and English language
• Risk Management
• Quality decision making
• Knowledge of compliance requirement for all internal and external regulations
• Knowledge of related industry GxP standards and processes Quality Standards

Minimum requirements
• Bachelor's degree in Chemistry and Pharmacy obtained by national university in Chile.
• Technical knowledge of Pharmaceutical/Chemical Analytics/Quality Control and equipment qualification
• Business level English (writing, speaking)

You’ll Receive
Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.

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!

Diversity & Inclusion / EEO

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

Minimum Requirements

• Bachelor's degree in Chemistry and Pharmacy obtained by national university in Chile.
• Technical knowledge of Pharmaceutical/Chemical Analytics/Quality Control and equipment qualification
• Business level English (writing, speaking)
Novartis Technical Operations
NTO QUALITY
Chile
Región Metropolitana
Quality
Full Time
Regular
No
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329133BR

Quality Control Associate

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