Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The PositionA healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.Roche fosters diversity, equity, and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient of success. We believe that inclusion is key to understanding the varied healthcare needs of people. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
- 12 Months Max-Term role within a diverse and collaborative team
- Regional exposure and cross border collaboration
- Fully flexible work environment
The RoleA
Quality Assurance Associate is responsible for leading and supporting a variety of activities to ensure the supply of products in compliance with applicable quality and regulatory standards.A
Quality Assurance Associate is passionate about ensuring quality medicines are supplied to patients and partnering with the business to provide seamless certainty of medicines supply to pioneer life changing healthcare for every Australian.
Key Responsibilities- A Quality Assurance Associate supports but not limited to:
- Rollout and implementation of the organization's Quality Plan
- Implementation and maintenance of Quality Systems required for GxP compliance to Health Authority and Roche PQS requirements
- Management of 3rd party compliance
- Reporting on relevant key performance indicators (KPIs) and provide data & trending, including reviews, critical analysis and recommendations
- Maintains the Quality System
- Local teams in both Regulatory and Roche Corporate GxP audits preparation and participates and/or lead Internal Audits as required
- Quality team in a variety of activities e.g deviation management, complaint management and reporting, and other quality operational tasks e.g product release for the New Zealand affiliate as required
- Ensures training requirements satisfy GxP and Roche PQS requirements
Who you are:You have- Degree in life sciences, pharmacy, medicines, or other healthcare discipline. Postgraduate qualification is highly regarded
- Gained sound professional experience in the pharmaceutical/ biotechnology industry, preferably in quality risk management or quality control at a local, regional or global level
- Thorough knowledge of PIC/S, ICH, TGA regulations with experience in a pharmaceutical manufacturing environment
- Knowledge of ERP systems (SAP preferred) and other quality systems management software is a plus
- Demonstrated decision-making experience in a complex and changing environment
- Experience with designing and delivering training programs for GxP programs desirable
This
12 MonthsMax Term role is only open to candidates that have full eligibility to live and work in Australia.We do not accept any unsolicited resumes or enquiries from recruitment agencies. Roche has a dedicated in-house Talent Acquisition team.
What do we offerIn return, Roche offers a competitive package, ongoing development, and opportunities for career advancement.Roche encourages a high-performance culture where you are empowered and trusted to make decisions. We strive for excellence and extraordinary results and take a genuine interest in our people and their well-being, and our patients.At Roche, the world’s largest biotech company you can, with the industry’s strongest pipeline in specialised medicines. Take pride in knowing you can make a difference to millions of patients worldwide developing treatments for oncology, neuroscience, inflammation, immunology, ophthalmology, rare diseases, and respiratory disease.Anything’s possible, in a friendly, collaborative culture where people are united in purpose and will stretch you to be brave, speak up and think differently. Feel empowered to deliver meaningful outcomes, supported by accessible and inspiring leaders.All facets of diversity are important to us and we endeavour to create an environment where everyone, regardless of factors such as gender, age, ability, race, ethnicity, sexual orientation, gender identification or religion, can contribute and realise their potential. As part of promoting diversity, we welcome applications from all people who are passionate about doing now what patients need next.We are committed to providing a safe, secure and healthy workplace, and to minimise any such impacts to our employees, customers and the community. In line with our vaccination policy all of our employees are required to be fully vaccinated against COVID-19. By applying for this role, you acknowledge your awareness of this policy and the requirement to comply if employment is secured. We encourage you to advise of any individual circumstances that may require consideration.
Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche is an Equal Opportunity Employer.
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