AdressAre you ready to take the lead in ensuring patient safety and maintaining License to Operate across our Development functions? As a Quality Advisor in Site Quality, you will be the prime source of GMP advice and leadership. You will interpret AZ regulatory and GMP standards into appropriate quality standards and provide guidance to ensure AstraZeneca and Regulatory requirements are met. This role requires independent operation, risk management and lean skills, and decision-making against a background of varying regulations and standards. Your responsibility will extend to internal assets and GMP compliance decisions, having a major impact on AZ's business.
Your role
As a Quality Advisor, you will develop and maintain knowledge of the quality regulations and guidelines applicable to your area. You will support colleagues, build strong customer relationships, and participate in GxP audits/initiatives. You will also be responsible for developing and approving GMP documentation and QA risk assessments, providing Quality input into business improvement projects, and part of GMP inspections. You will work closely with our customers to set direction for quality within that area, maintaining quality oversight and driving continuous improvement.
Most appreciated in the role is the ability to be part of projects, to improve processes or ways of working and by supporting different functions with your subject matter expert knowledge. Working close to research manufacturing makes your role versified and enables lifelong learning in everyday tasks.
Essentials
- Appropriate scientific degree with experience (2-5 years) of working within a pharmaceutical GMP environment, preferably within a pharmaceutical development organisation
- Experience from working in a Quality Assurance function
- A broad and comprehensive understanding of Quality Systems and GMP
- A comprehensive understanding of the pharmaceutical/drug development process
- A scientific understanding of the Product types being supported
- Good knowledge and reputation in the QA arena and specifically in GMP matters
- Understanding of Supply Chain processes
You thrive when you work independently, when leading projects and take pride in structuring your day, knowing that the diverse workload can change the schedule with little notice. You are a problem solver who can look at solutions in a pragmatic way - coming up with creative solutions whilst still following our strict regulations.
Desirables
- Excellent team working and networking skills
- Demonstrates independent judgement and uses risk management in complex situations
- Capable of making decisions, acting courageously and communicating with conviction and inspiration
- Demands excellence (sets high bar) and delivers
- A good communicator with experience of interacting effectively across interfaces
- Builds excellent relationships both internally and with external suppliers or service providers
Why AstraZeneca
At AstraZeneca, we take Quality seriously. Our work is important, valued, and at the forefront of discovery, development, and commercialisation. We are always innovating, trialing the latest models and technologies to improve reliability and excellence in our processes. We are proactive, science-based, and driven by our ambition to go far. We are a team of ambitious people who want to achieve. We work together as a team, get our pipeline out to patients sustainably, reliably, and safely. We follow evidence to reach outcomes that benefit patients and AstraZeneca.
Make a difference! Apply now and join us in our journey to push the boundaries of science and make a real-life difference to patients.
Welcome with your application no later then 19th Mars.
Date Posted
05-mars-2024
Closing Date
19-mars-2024
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
