Quality Assurance Specialist

Do you have expertise in Quality Assurance and a passion to play a critical role as the eyes and ears of our patients?  If you have the passion and the drive to accelerate growth and make people’s lives better - then AstraZeneca is the place for you.

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation 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 unlock the power of what science can do. Empowered to explore, everyday we work towards our ultimate aim – treating, preventing, modifying and even curing complex diseases.

BUSINESS AREA

In Quality, our work is important and valued. An unrivalled forward-looking mindset, there’s no better place to work at the forefront and learn how to add real value to a business throughout the lifecycle of our products – discovery, development and commercialisation.

As the voice of the patient, every batch we certify is a personal stamp of approval. Not something we take lightly, we are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes.

What you’ll do

Provides Quality Assurance support to an assigned area, including out of hours support. Develop, support, and drive excellence in MCOQ GMP & GDP Quality activities to maintain the local License to Operate. Serve as the primary point of GMP & GDP contact and maintain an effective governance structure to ensure oversight of quality activities. Non-supervisory, act as back up to MCOQ/QP for MC.

General Accountabilities:

• 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.

• Participates in development of Global AZ MCOQ Quality Strategy and executes country strategy for MCOQ Quality and Marketing Company GMP/GDP aligned with AZ’s bold ambition strategy for market expansion, product launches and accessibility.

• Accountable for assurance of compliance with worldwide standards for all local GMP & GDP activities and connects the MC offices the broader Operations Quality and R&D organisation operating under One AZ QMS

Typical Accountabilities:

• Participate in defining the strategy for the commercial global markets and the execution of Affiliate GMP and GDP Quality System and framework in MC Indonesia.
• Define, develop, deploy, and monitor GMP/GDP policies and standards in MC Indonesia to ensure compliance with regulatory requirements.
• Ensure compliance assurance by working to one set of GMP & GDP standards and processes, including common GxP processes across the Affiliate GxPs.
• Support GMP & GDP activities impacting the MCOQ organization in the country.
• Support the Affiliate Quality Management Review process, preparation, execution, and escalations to senior leadership.
• Drive global standardization, simplification, and improvement of MCOQ Quality business processes.
• Develop and sustain a high-quality organization that continuously improves in competence, compliance standards, and innovative delivery of results.
• Provide training, support, and coaching related to Quality topics for Affiliate Quality network roles and MC Indonesia employees.
• Ensure country-specific regulatory requirements related to the manufacture and distribution of AZ products are met, including product release, issue management, recalls, and compliance with local regulatory agency interactions.
• Lead troubleshooting activities to resolve existing problems, make complicated judgments, and anticipate future developments in Quality-related needs.
• Manage Quality Standards and expectations across a broad range of services to provide high-quality, timely, and cost-effective service.
• Ensure adherence to Quality, Health, and Safety, GMP, GDP, and regulatory requirements.
• Carry out compliance reviews and reporting for external suppliers, including issue resolution with senior management and AZ site leaders.
• Prepare the country for Regulatory Agency and AstraZeneca inspections/audits, manage responses and to develop follow-up improvement plans to ensure ongoing compliance
• Support local MCOQ to deliver the license to operate, including GMP & GDP audits and inspections, and implement effective self-assessment programs.
• Ensure QMS compliance and continuous improvement in the country, with timely management and closure of issues.
• Promote a Quality Culture within MCOQ, setting strategy for GMP/GDP excellence in the region and locally.
• Achieve country KPIs and objectives/Quality Plans, and address trends through continuous improvement plans.
• Contribute to the development of procedures in the area of specialism and provide technical input into global standards for function and globally and serve as lead editor for GxP documents uploaded into the ECMS system.
• Identify opportunities for change, make efficiency savings, influence decisions, and deliver results while maintaining appropriate levels of compliance.
• Actively participate in working groups, teams, and projects to provide a global perspective and drive consistency and standardization in Quality and GMP compliance.
• Establish and maintain business continuity plans in the GMP/GDP area.
• Act as Subject Matter Expert (SME) for GMP & GDP activities impacting the affiliate organization in MC Indonesia.
• Support Affiliate GMP & GDP input into divestments, acquisitions, and licensing agreements in MC Indonesia.
• Report significant changes in the GMP/GDP area and take action as necessary.
• Perform batch review, commercial batch release, and act as deputy for product release activities, recommending batch disposition to the Logistic Service Provider.
• Collate the required documentation for product quality reviews within the required timescales.
• Identify and manage the first level of risk using analytical skills and experience to make decisions and develop solutions.
• Act as a local recall administrator, supporting the MCOQ Lead to ensure an effective local product incident process is in place to escalate and manage product quality incidents.
• Manage QMS/GMP/GDP materials to ensure a good archiving system is in place.
• Management of Product Quality Complaints.

Essential for the role

• Apothecary Degree with 1-2 years of working experience in QA Function.
• Good communication skill
• Sound knowledge/understanding of the principles and concepts of compliance management and Good Manufacturing Practice/Good Distribution Practice

Why join AstraZeneca?

We are driven by our commitment to deliver accelerated growth for AstraZeneca and to make people’s lives better. It pushes us to keep building on our foundations and progressing as we turn our ever-growing and increasingly complex pipeline from molecule to medicine. Be part of evolving how we work with Lean, cutting-edge science, digitalisation and sustainable practices.

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
• If you’re curious to know more then please reach out to Aziza Fitriani. We welcome your application.

Where can I find out more?

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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.