Quality Assurance Specialist " >Quality Assurance Specialist


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, among others. 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, that are highly organized, with great communication skills and high motivation to learn and accept new challenges.

Your responsibilities:
Your responsibilities include, but are not limited to:
• Ensure that all incoming drug products are inspected prior to release to the market in accordance with the current in place procedures, registered specifications and with local/international regulations.
• Ensure that all aspects of the handling and distribution of pharmaceutical products in the country comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements.
• Ensure that Change requests, are managed according to the Novartis SOPs from receipt, through the implementation and closure.
• Conduct GxP monitoring on all sections, conduct QA investigations and follow up or corrective/preventive actions.
• Coordinate implementation of quality system and procedures for the implementation of Novartis Quality Manual and quality agreements.
• Ensure that a local Quality System and Standard Operating Procedures are in place for all cGMP/GDP related activities and that compliance with cGMP/GDP regulations is maintained through training and internal audits.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country.
• Ensure that coordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance.
• Manage complaints, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures.

What you’ll bring to the role :
• Operational Excellence
• Continuous Learning
• Breakthrough Analysis
• Spanish and English language

Minimum requirements
• Bachelor's degree in Chemistry and Pharmacy obtained by national university in Chile.
• Minimum 2 years working experiences in the pharmaceutical industry with direct experience in QA/QC operations.
• Business level English (writing, speaking)

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.
• Minimum 2 years working experiences in the pharmaceutical industry with direct experience in QA/QC operations.
• Business level English (writing, speaking)
Novartis Technical Operations
Región Metropolitana
Full Time
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Quality Assurance Specialist

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Source URL: https://www.novartis.com/careers/career-search/job-details/329132br/quality-assurance-specialist

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