QA Associate

5 million. This is the number of products that Sandoz, a part of the Novartis Group of Companies, distributes into the Australian & New Zealand market every single month. Being the generic market leader in Australia and growing in NZ; we need to ensure Ensures adherence to Good Clinical Practice (GCP) and quality standards across ANZ.
- In this role, you’ll manage the Quality aspects and projects within an area of responsibility and support the overall GxP conformity and Compliance with the Sandoz Quality Management Systems.
- Your responsibilities include, but not limited to:
- Ensure that Change requests, are managed according to the Sandoz SOPs from receipt, through to the implementation and closure.
- Conduct GxP monitoring on all sections, conduct QA investigation for non-compliance and follow up on corrective actions with proper documentation
- Ensure that all aspects of the handling and distribution of pharmaceutical products in the country comply with the requirements of the Sandoz Quality Manual and Policies and meet all 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 and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country.
- Establish a good working relationship with the Supply Chain Management (SCM), DRA and Medical departments, Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) 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.
- Ensure that an effective Change Control process is in place.
- Manage complaints, recalls, counterfeits and product tampering according to the Corporate Quality Manual and local written procedures

**Commitment to Diversity & Inclusion**:

- 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:
- Typically requires a Bachelor’s degree or equivalent in education and experience
- 1 - 3 years’ experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, production, distribution or a directly related area
- Familiarity with cGMP/GDP quality systems and procedures is an advantage
- Experience in technical writing and quality assessment is preferred
- Prior change management and project management experience is preferred
- Ability to work in a fast-paced environment; problem solving ability
- Great teammate, highly collaborative, positive, and can-do attitude

Why Sandoz?
- 500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
- How will we do this? 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 Sandoz

**Division**
- Novartis Technical Operations

**Business Unit**
- QUALITY

**Country**
- Australia

**Work Location**
- Sydney

**Company/Legal Entity**
- AU Sandoz Pty ltd

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No