Quality Assurance Specialist

4 months ago

Johannesburg, South Africa AstraZeneca Full time

Do you have expertise in, and passion for working in Quality Assurance and creating value for our customers and patients? If so, AstraZeneca might be the one for you_

**_ ABOUT ASTRAZENECA_**

AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development. Our strategic priorities reflect how we are working to deliver our strategy and achieve our Purpose. As a workforce, we are the catalyst for our values: we are entrepreneurial; we do the right thing; we play to win; we put patients first and we follow the science. As a company we appreciate and take great pride in each team member where every person is brought together through shared values, that underpins a shared purpose. There’s no better place to feel inspired and energized.
At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Join the fastest-growing pharmaceutical in our markets, set up to fuel further growth. Be part of our shared ambition and pride: our strong heritage, our turnaround story, and early investment and commitment in International markets. There’s no better place to feel inspired and energized.

**_ ABOUT OUR QUALITY ASSURANCE TEAM_**

Our Quality Assurance team is highly respected and regarded in the African Cluster and in the global Marketing Company Operations Quality (MCOQ) network. The Cluster consisting of Sahara/French Speaking Africa countries and South Africa, is part of the MEA team. We are known for our knowledge and to go the extra mile to get quality products to our patients but at the same time not compromising on Quality Management principles. We know that we cannot fulfil our ambitions alone. We excel

by regular interacting with the other internal departments and having great relationships with our contract distributors. We are part of the global operations quality team to ensure keeping on top of ever-changing requirements or trends ensuring constant development opportunities.

We are part of the local MC GxP network together with the regulatory and patient safety departments. We have the right attitude to go with it. With a “do the right thing” and ongoing communication mindset, we learn from others and ensure we continuously improve the quality management system. Action-oriented, we take calculated risks to make quick decisions but never compromise product quality, safety, or effectiveness.

**_ What you will do:_**

You will be managing the Quality Assurance/critical player for the African cluster countries who in turn is part of the MEA region MCOQ. You will be a critical player in ensuring the success of the African cluster MCOQ by managing the Quality Management System.

**_ Job Description_**
- Participates in the development of Global AZ Affiliate Quality Strategy and executes country strategy for Affiliate Quality and Marketing Company GMP/GDP aligned with AZ’s 2030 bold ambition strategy for market expansion, product launches and accessibility.
- Is the responsible party for overseeing the design, implementation and delivery of a common Quality system and strategy for GMP and GDP activities across in Commercial marketing company for all of the AZ product portfolio in country
- Accountable for assurance of compliance with worldwide standards for all SA MC GMP & GDP activities and connects the affiliate offices the broader Operations Quality and R&D organisation operating under One AZ QMS.

**_ Typical accountabilities will include:_**

For the African Cluster develop, support and drive excellence in Affiliate GMP & GDP Quality activities to maintain the MC License to Operate in the African cluster.

Point of GMP & GDP contact for the country and maintains an effective governance structure to ensure oversight of quality activities.
- Provides input for GMP & GDP (Good Manufacturing and Good Distribution Practice) strategy and activities across market and commercial SET area as the Quality partner to Commercial SET leader, Regional Commercial Head and Global Safety
- Participates in defining the strategy for the commercial global markets ownership and execution of Affiliate GMP and GDP Quality System and framework in African cluster
- Participate in defining, developing, deploying and monitoring the GMP/GDP policies and standards and execution in country market
- Assist with SA MC Affiliate Quality Mana

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