Central Quality Specialist (12 month fixed term contract)

Are you ready to make a difference in the pharmaceutical industry? We are seeking an experienced Quality Assurance Specialist to join our dynamic team. In this pivotal role, you will ensure the integrity, accuracy, and compliance of quality records within our pharmaceutical manufacturing environment. Your expertise will support our Quality Management System (QMS) by managing quality records and ensuring adherence to GxP and regulatory standards. 

Accountabilities
• Managing and maintaining quality records in compliance with internal procedures and regulatory requirements (e.g., GxP, 21 CFR Part 11).
• Supporting the delivery and execution of Quality Records.
• Using electronic systems (Veeva) for document and record management.
• Authoring, reviewing, and maintaining GxP documentation.
• Ensuring compliance with GxP guidelines and regulatory requirements in all documentation and quality systems activities.
• Maintaining thorough and accurate GxP documentation to support compliance and inspection readiness.
• Providing guidance on quality record management best practices.
• Providing forward-thinking innovative solutions and identifying opportunities to add value to the team's deliverables.
• Other duties, as required, to support the growing Quality organization.

Essential Skills/Experience
• Bachelor’s degree in Life Sciences, or a related technical field.
• 3+ years of experience in a Quality role within the pharmaceutical industry and working to GxPs.
• Strong understanding of QMS components (deviations, CAPAs, audit, change controls).
• Knowledge of requirements for a Quality Management System.
• Experience with GxP documentation and regulatory compliance.
• Experience in authoring, reviewing, and maintaining GxP documentation to ensure regulatory compliance.
• Direct experience and comprehension of systems supporting pharmaceutical manufacturing, IT infrastructure, and/or laboratory operations.
• Business engagement skills, with the ability to partner with both technical and non-technical roles.
• Able to prioritize and manage workload and manage shifting priorities based on criticality to ensure commitments are met.
• Ability to work to tight deadlines.
• Strong understanding of GxP guidelines and compliance requirements.

Desirable Skills/Experience
• Analytical problem-solving skills applied to issue identification and resolution.
• Integrating diverse perspectives to add value to the achievement of team goals and timely decision-making.
• Project management skills combined with a sense of urgency and a proven history of producing quality deliverables.
• Experience in supporting Audit and Inspection activities, CAPA, follow-up.
• Experience with quality management system software such as Veeva.

At AstraZeneca, we are driven by a passion for innovation and a commitment to making a meaningful impact. Our culture is rooted in integrity, inclusiveness, and dedication to supporting the communities we serve. We believe in empowering our employees with tailored development programs that foster a deep understanding of our patients' journeys. Join us in our mission to change lives for the better, where every day builds a better tomorrow.

If you're ready to embark on a journey that truly counts, we invite you to apply today!

Date Posted

21-Nov-2025

Closing Date

04-Dec-2025

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.