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

ABOUT ASTRAZENECA
Astra Zeneca is a global, innovation-driven Bio Pharmaceutical 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 Astra Zeneca 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 Astra Zeneca, 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 Gx P 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 Management Review process, preparation and execution and escalations to Operations, Commercial and R&D Sr. Leadership and SET members
  
• Represents Quality on cross-functional and cross SET teams and steering committees related to Affiliate market.
  
• Participates in driving global standardisation, simplification and improvement of SA Affiliate Quality business processes. Participates in developing and sustaining a high-quality organisation that delivers against global processes, and aims to continuously improve in competence, compliance standards and innovative delivery of results.
  
• Participates in providing training, supporting and coaching structure for regional Quality Affiliate network roles.
  
• Participates in strategy and regional objectives setting for the Affiliate Quality organisation
  
• Is the secondary point of expertise for GMP & GDP activities impacting the MC affiliate organisation
  
• Accountable for compliance assurance and working to one set of GMP & GDP standards and processes, as well as common Gx P process across the Affiliate Gx Ps.
  
• Accountable for Country specific regulatory requirements related to manufacture and distribution of AZ product in country, including but not limited to release of product batches, resolution of Issue Management, recalls, influence and decisions on MC regulatory agency interactions, audits and inspection readiness and compliance to gain and maintain AZ license to operate.
  
• Share in responsibility for Affiliate GMP & GDP input into divestments/acquisitions/licensing agreements in country
  
• Demonstrated ability to work independently and in project settings to deliver objectives.
  
• Keeps own knowledge of best practices, industry standards and new developments in quality management up to date.
  
• Participates in trouble shooting activities to resolve existing problems, make complicated judgements and anticipate future developments in Astra Zeneca’s Quality related needs
  
• Responsible for managing Quality Standards and expectations across a broad range of services in order to provide a high quality, timely and cost-effective service
  
• Employs prepared information to discuss, plan and help carry out improvement plans, priority setting, investigation reports, quality or performance improvement recommendations
  
• Ensures adherence to Quality, Health and Safety, Good Manufacturing Practice, Good Laboratory Practice and regulatory requirements of own work and others work
  
• Responsible for ensuring that policies and standards meet regulatory requirements
  
• Ensures compliance with Good Manufacturing Practice, Safety Health and Environment and all other relevant regulations
  
• Carries out compliance reviews and reporting for external suppliers including issue resolution with senior management and AZ site leaders, this may include, but is not limited to, the review and approval of investigation reports and participation in issue management teams
  
• Assisting with responsibility for MC preparing for Regulatory Agency and Astra Zeneca inspections/audits and responses
  
• Supports MC to deliver the license to operate, including but not limited to support for GMP&GDP audits and inspections, implementation effective self-assessment programs in the country of responsibility.
  
• Responsible for ensuring QMS compliance and continuous improvement in the Region and all issues are managed concerned and closed on time, risks are identified and escalated to Global Quality.
  
• Promotes a Quality Culture in the Affiliate sets strategy in the region and in MC for execution of GMP/GDP excellence.
  
• Responsible for the achievement of country KPIs and objectives/Quality Plans. Ensure country trends are addressed through development of country continuous improvement plans.
  
• Adheres to Good Manufacturing Practice and Safety Health and Environment and ensures regulatory compliance
  
• Contributes to development procedures in area of specialism and provides some technical input into the development of global standards for function and globally
  
• Proactively looks for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring and appropriate level of compliance
  
• The jobholders are directly involved with/lead working groups, teams, and projects to proactively provide a global perspective and to drive consistency and standardization in all matters related to quality and GMP compliance
  

Specific Requirements:

• Quality Management Review (QMR) Process Management
  
• Management of Product Quality Complaint & Champion /Reconciliation with Patient Safety
  
• Quality Issue/Deviation Management
  
• CAPA & CAPA Effectiveness Management
  
• Quality Risk Management & Risk Register
  
• Change Control Management
  
• Temperature Excursions (Logistic Incidents)
  
• Post Importation testing (Samples and Reference Standard management) and exemption application(PITE)
  
• Technology transfer to local labs involving manufacturing sites
  
• Product launches
  
• Product Quality Review
  
• Quality Assurance Agreement
  
• Mock Recall/Recalls/IMT
  
• Physician Sample management
  
• Customer verification Management
  
• Vendor Oversight (Contract laboratories, Distributors)
  
• Maintains the MC Quality Assurance (QA) Standard Operating and all other documentation in EQV
  
• Manages coaching/training on GMP/GDP including QA documentation
  
• Assists with internal audits for Gx P related activities.
  
• Assist with audits by Health Authority or Global Quality Audit (GQA) group
  
• Business Continuity Plan
  
• Product Security
  
• Section 21 releases / pre-reg shipment
  
• Induction/Onboarding New Employees
  
• Continuous Improvement Plan
  
• Pack conversions
  
• Final Product Release for sale including all relevant processes in SA
  

If this sounds appealing, please read on to understand the experience and skills we’re looking for…

ESSENTIAL SKILLS & EXPERIENCE REQUIRED

• Completed B.Pharm Degree and registration with SAPC
  
• 3 years plus experience of Quality Assurance in the pharmaceutical industry
  
• Solid understanding of the Good Manufacturing/Distribution Practice in the Quality environment
  
• Preference would be given to candidates with knowledge or experience in African Countries requirements
  
• Strong communication and influencing skills
  
• Coaching & Feedback – Leadership skills
  
• Attention to detail
  
• Problem Solving
  

Why Astra Zeneca?

We are proud to have achieved Top Employer certification in South Africa, Kenya, and Nigeria, as well as our Best Place To Work certification in Cote d'Ivoire, Cameroon, and Senegal. It is the fourth year South Africa and Kenya have been awarded the Top Employer certification. Amongst the world's top 30 workplaces in 2023 This distinction is a confirmation of our commitment and ability to sustain people, partnerships, and employee engagement and foster an innovative workplace environment.

At Astra Zeneca, 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, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. 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.

SO, WHAT’S NEXT?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!
Click the link to apply no later than 10 September 2024 and we’ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow Astra Zeneca on Linked In https://www.linkedin.com/company/1603/
Follow Astra Zeneca on Facebook https://www.facebook.com/astrazenecacareers/

Close Date: 10/09/2024