Quality Assurance Support Officer
Location: Cheshire East
Job Type: Full time
Quality Assurance Support Officer
Competitive Salary and Benefits
Open Date: 13/02/2024
Close Date: 27/02/2024
Make a meaningful impact on people’s lives with life-changing medicines
Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better – from patients and their families to all of us in society. In Quality, our work is important and valued. An unrivalled forward-looking attitude, 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. We now have a fantastic opportunity for a Quality Assurance (QA) Support Officer to join our team!
In this role, you'll be responsible for providing the post marketing archiving service for documentation and samples. In addition, you'll provide specific pre-marketing activities for package inspection, sampling or re-sampling of incoming materials, (package components, raw materials, bulk drug and excipients) and provide pre marketing QA data validation on phase-allocated packs against source information, using GMP quality checklist.
What you'll do:
- Hold accountability for completing all the aspects of archiving for Macclesfield Operations on site or via external liaison in line with Quality standards.
- Complete all aspects of inspection, sampling or testing for certified, part certified or non-certified components and starting materials.
- Assess the suitability of temperature data loggers used in transportation.
- Complete the quality assessments and decision for critical package components.
- Proactively look for opportunities to identify change and make efficiency savings whilst ensuring an appropriate level of compliance.
- Ensure local readiness for internal and external audits and inspections.
- Contribute to the resolution of Quality Notifications, Laboratory Investigations and customer complaints ensuring investigation actions are completed on time and in full.
- Experience of working in a GMP environment with proficient knowledge of current GMP requirements and regulatory processes
- A comprehensive understanding of how the quality assurance function operates, as well as an understanding of other functions and how they contribute to achieving the objectives of the business within a lean manufacturing environment.
- Good knowledge of IT systems used by the Quality Department and foundation financial governance (fiscal awareness)
- Knowledge of AstraZeneca Health & Safety (SHE)
- Previous experience in a similar role would be advantageous but not essential
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 this role works five 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.
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.
A place to take Quality seriously. we draw learnings from others, to develop and understand what it takes to drive our modern mindset forward. Here you'll feel empowered to step up, follow the science and evidence to make decisions that put patients first.
Are you ready to make a difference? Apply now!
Closing Date26-Feb-2024Our 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.