Quality Specialist - Romania

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Quality Specialist

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.

We are now looking for a Quality Specialist that will be involved in the design and execution of a common quality management system (QMS) and strategy for GMP and GDP activities across the Commercial Marketing Company (MC) for the AZ product portfolio in country. Additionally, act as a backup for Pharmacovigilance system/tasks.

You will report into the CEEBA cluster lead and be part of the Global Quality Organisation.

Main tasks and responsibilities:

  • Provide leadership in alignment with regulatory and corporate requirements for Quality, GMP & GDP (Good Manufacturing and Good Distribution Practices) strategy and activities across the market as the Quality business partner to the Commercial leader.

  • Accountable for assurance of compliance with standards for all local GMP & GDP activities. Define, develop, deploy and monitor the GMP/GDP policies, standards and procedures and execution in country market, being the primary point of contact.

  • Responsible for ensuring QMS compliance, that risks are identified and raised to Global Quality and achievement of country critical metrics and objectives/Quality Plans, ensuring country trends are addressed through development of country continuous improvement plans.

  • Supports global standardisation, simplification and improvement of MCOQ Quality business processes and connecting the MC office to the broader Operations Quality and R&D organisation operating under One AZ QMS.

  • Represents Quality on cross-functional teams and steering committees related to MC.

  • Lead working groups, teams, and projects to provide a global perspective and drive consistency and standardization in all matters related to quality and compliance.

  • Accountable for Country specific regulatory requirements related to manufacture and distribution of AZ product in country, e.g. Release of product, resolution of Issue Management, recall administrator, training, supplier qualification, management review, influence and decisions on local regulatory agency interactions, audits and inspection readiness and compliance to gain and maintaining the AZ licence to operate

Your Profile:

  • University degree in pharmacy, life sciences or related field.

  • Experience in Bio/pharmaceutical industry within Quality or Pharmacovigilance space.

  • Experience in GDP, GMP and ideally GPV (Good Pharmacovigilance Practice)

  • Proven track record to work independently and in project settings to deliver objectives.

  • Able to lead trouble shooting activities to resolve existing problems, make complicated judgements and anticipate future developments.

  • Strong communication and influencing skills.

  • Project and people management.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a phenomenal Place to Work. Where you are empowered to push the boundaries of science and ignite your ambitious 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.

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Please apply by submitting your CV via our global career website.

Where can you find more?

Our Social Media, Follow AstraZeneca on LinkedIn

Follow AstraZeneca on Facebook

Follow AstraZeneca on Instagram

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.

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