Operations Quality Specialist
5 meses atrás
Marketing Company Operations Quality Specialist
Introduction to Role:
Join our team as a Quality Specialist, within the global organization Marketing Company Operations Quality (MCOQ), where you'll manage all required activities, tasks, and processes to ensure compliance with Good Distribution Practices of Medicinal Products for Human Use (GDP), local laws and regulations, and AstraZeneca's internal requirements for GMP and GDP. This is your chance to accelerate our Lean journey and drive efficiencies in our processes
Act as a back up of the AstraZeneca Technical Director, for the wholesaler distribution activity of medicinal Products in Portugal.
Accountabilities:
As a MCOQ Specialist, development, support and drive excellence to the AstraZeneca GMP/GDP Quality Management System (QMS), in compliance with any specific legal requirements in the Country.
You'll be responsible for a wide range of activities within the QMS. These include maintaining the Local Quality manual and Local SOPs/Work Instructions, managing change control, deviations, complaints, customer and supplier management, self-inspections, training, CAPA management, risk assessment, quality performance tracking, local batch approval for sale, management of returns with potential for stock reintegration, technical and regulatory interface/support with Logistics Service Provider and other AstraZeneca relevant functions.
As a back up for the Technical Director , ensure the compliance with Good Distribution Practices of Medicinal Products for Human Use and applicable laws and regulations, contributing to audit and inspection readiness status, so that business maintains its license to operate and to ensure that public service obligations are met.
Essential Skills/Experience:
University Degree in Pharmacy/Pharmaceutical Sciences Fluent in local language and English. Demonstrated expert-level knowledge on Good Distribution Practices of Medicinal Products for Human Use, applicable laws and regulations. Experience in quality assurance within the pharmaceutical manufacturing or distribution environment, including experience in compliance reporting and in quality performance tracking. Experience on the use of computerised pharmaceutical quality management systems. Good level of understanding and knowledge of distribution related processes.Desirable Skills/Experience:
Strong teamwork skills. Strong adaptability and flexibility. Analytical, detail driven. Ability to manage multiple tasks and priorities simultaneously. Ability to work under strict timelines, combined with flexibility when emergency situations require this. Focus on internal and external customers, assessing and prioritizing their needs. High ethical standards.When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca?
At AstraZeneca, our work in Quality is important and valued. We're always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. We're proactive, science-based, solutions-oriented, and our ambition keeps pushing us forward. We're strong communicators and networkers who work together as a team to get our pipeline out to patients sustainably, reliably and safely. We follow evidence to reach outcomes that benefit patients and AstraZeneca. With our digital and Lean evolution in Operations, we focus on patient-centricity, constantly asking what more we can do to deliver to patients safely. Join us as we continue to grow a fulfilling and exciting career with constant opportunities resulting from new products, technologies and growing areas like biologics.
Ready to make a real-life difference to patients? Apply now and join our ambitious team
Date Posted
17-jun.-2024Closing Date
01-jul.-2024-
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