343721BR
Apr 12, 2022
Australia

Job Description

6! Strong values define our culture and help us executive Novartis strategy in line with our mission and vision. These values and behaviors are Innovation, Quality, Collaboration, Performance, Courage and Integrity.

The QA Associate’s role is to handles quality aspects and projects within area of responsibility. QA Associate also to ensure and support overall GxP conformity and compliance with the Novartis Quality Management Systems.

Your responsibilities include, but not limited to:

• Ensure that Change requests, are handled according to the Novartis SOPs from receipt, through to the implementation and closure. Conduct GxP monitoring on all sections, conduct QA investigation for non-compliance and follow- up the corrective actions.
• Coordinate implementation of quality system and procedures for the implementation of Novartis Quality Manual and quality agreements.
• Ensure that all aspects of the handling and distribution of pharmaceutical products in the country align with the requirements of the Novartis Quality Manual and Policies, meet relevant cGMP regulatory and legislative requirements.
• 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 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 (and Global Quality Assurance.
• 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.
• Handle complaints, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures.


Diversity & Inclusion / EEO

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:

To be successful in this role, you will bring:

• Tertiary qualification in Sciences (Chemistry or other Life Sciences)
• At least a couple of years working experience in related QA role
• Knowledge of CAPA and good documentation practice
• Good communication skills and ability to impact, influence and collaborate with key partners
• Attention to details. Excellent communication skills
• Problem solving and a good teammate

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 hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Novartis Technical Operations
NTO QUALITY
Australia
Sydney
Quality
Full Time
Regular
No
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343721BR

Quality Assurance Associate

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