Role: Clinical Supply Quality Events Associate
Role Type: Temporary
Location: Macclesfield (First 3 months, will be 5 days per week on-site. 3 Months onwards – x3 days on-site + 2 working remote per week).
Your New Company:
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
In Pharmaceutical Technology and Development (PT&D), we are the bridge between brilliant science and innovative medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices required to support new medicines – from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.
The Clinical Supply Quality Events Associate supports the clinical supply management team with task-based activities relating to quality events i.e. Deviations and Product Quality Complaints, to ensure compliance in the delivery of materials to clinical trial patients.
This role is a great opportunity for someone who wishes to develop their quality and compliance understanding in the agile, vibrant and global environment of clinical supply management.
What You Will Do
* Document the intake of Product Quality Complaints and Deviations ensuring they are reported in the Enterprise Quality Vault within expected timelines.
* Coordinate sample returns of Product Quality Complaints.
* Monitor the incoming Product Quality Complaints and ensure they are attended to by the global team.
* Support the Clinical Supply Quality Events Lead in preparing for and facilitating the weekly Pulses meeting.
* Facilitation of Deviation Investigations.
* Quality Events quarterly review data retrieval and presentation preparation.
* Develop process standards and training material around Quality Event Management.
* Ad hoc support with task-based activities to support the Global Clinical Supply Associate Team.
In this role you will have the opportunity to work with multiple customers and partners internally and externally across all phases of the drug development lifecycle, covering small and large molecule drug products. You will follow SHE and GMP standards and will be personally accountable for these areas within your own work plans.
Essential Skills
* Experience of working in a GXP environment up to 2 years
* Organized and structured with an excellent aptitude for digital systems.
* Excellent time management and ability to meet agreed timelines.
* A team player who is comfortable in a high paced and agile working environment.
* Academic degree in a scientific discipline or supply chain management
* Passion for Quality and Processes
WHY ASTRAZENECA?
It's an exciting time to join AstraZeneca, a global business that's rapidly growing - there's a lot happening and even more to come. And we are a valued part of this journey. Respected partners across the business, we provide the platform that's going to power us to achieve more.
So, what's next?
Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have one seat available, and we hope it's yours. Please apply with a copy of your CV.
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 regardless of their characteristics. We align with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification