Job Description

Do you have expertise in, and passion for science working in Quality Assurance field? 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 worldxe2x80x99s most serious disease. But wexe2x80x99re more than one of the worldxe2x80x99s leading pharmaceutical companies.

At AstraZeneca wexe2x80x99re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Therexe2x80x99s 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.

ABOUT OUR SOUTH AFRICA QUALITY ASSURANCE TEAM

Our Quality Assurance team is highly respected and regarded in the MC and in the global MC Operations Quality network. 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 & laboratories. 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 GXP network together with the regulatory and patient safety departments.

We have the right attitude to go with it. With a xe2x80x9cdo the right thingxe2x80x9d 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 compromising product quality, safety or effectiveness.

What youxe2x80x99ll do?

The successful candidate will drive and manage the complete final product release for sale responsibility including post importation testing in SA, as delegated by responsible pharmacist, by prioritizing testing. You will be strongly involved in the method transfers or applications for exemption from post importation testing from SAHPRA before launch of the new products. You will assist with handling product quality complaints from customers.

You will also participate in regular meetings and interact with internal local & global AZ teams as well as external teams. You will assist with preparations for local MC GxP meetings.

You will manage local product quality reviews and managing the Quality Assurance department Standard Operating Procedures.

You will assist in managing the quality management systems e.g. review of deviations, managing changes, performing self-inspections/audits, managing continuous improvement plan, managing risks, managing training etc.

Typical accountabilities will include:

Final Product Release in SA including sample & priority test management. Performing full Batch documentation audits. Maintenance of Reference Standard supply.

Managing of product quality complaints.

Performing local SA Product Quality Reviews.

Maintaining QA SOPs & master documentation.

Assisting QA Manager in managing GxP/GMP/GDP Compliance.

Assisting with Applications for Post Importation Exemption Applications to Health Authority.

Managing & assisting with deviations, root cause analysis and investigations and use judgement to approve or reject product within tight business deadlines.

Managing changes in QMS system as part of GxP Team

Produce and deliver QA training where needed.

Manage self-inspections of Quality Management Systems as part of GxP Team.

Ensure Quality Assurance readiness for any external inspections.

Attend Quality Assurance meetings and aid in developing follow up improvement plans to ensure ongoing compliance.

Assist with method transfers.

Back-up to QA Manager.

Supplier & Contractor QA Management including QAA Agreements.

Look for opportunities to identify change and make efficiency savings, influence decisions, and deliver the results whilst ensuring an appropriate level of compliance.

Drive out any non-value adding activities and support lean operations and support line management to develop a culture of continuous improvement.

Maintained stakeholder relationships- e.g., distributor, global Distribution/QA

Archiving of QA documentation.

If this sounds appealing, please read on to understand the experience and skills wexe2x80x99re looking forxe2x80xa6

ESSENTIAL SKILLS & EXPERIENCE REQUIRED?

Essential

Bachelor of Pharmacy degree or diploma - registered pharmacist with SA Pharmacy Council.

Sound knowledge and understanding of the principles and concepts of QMS (Quality Management Systems).

Uncompromising attention to detail and accuracy.

Ability to analyze and evaluate data.

Excellent time management, planning and prioritization skills.

Desirable

Action orientated/ Sense of urgency.

Ability to form partnerships, build and maintain relationships.

Ability to work independently.

Excellent ability to work according to global standards.

Excellent written and verbal communication skills.

Strong interpersonal skills with a customer relationship focus.

Persistent drive for results in a fast-paced environment, utilizing sound project focus, organizational and problem-solving skills.

Why AstraZeneca?

At AstraZeneca wexe2x80x99re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Therexe2x80x99s 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. Wexe2x80x99re 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. Therexe2x80x99s no better place to feel inspired and energized.

SO, WHATxe2x80x99S NEXT?

Are you already imagining yourself joining our team? Good, because we canxe2x80x99t wait to hear from you!

Click the link to apply no later than 20 September 2023 and wexe2x80x99ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn

Follow AstraZeneca on Facebook

Date Posted 14-Sept-2023

Closing Date 20-Sept-2023

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca