This is what you will do:
The QC Specialist is responsible for technical and quality oversight for Transfer and Validation Activities within the Chemistry and Biochemistry Labs.
You will be responsible for:
Driving the validation and transfer of Chemistry and Biochemistry test methods and test systems in support of in-process and commercial release testing
Author/ review and approval of laboratory validation protocols /reports as required
Critically assess test procedures, analytical validation/transfer reports for accuracy and propose improvements/enhancements.
Perform review of regulatory submissions
Support the introduction of automation and rapid techniques within QC and the implementation of analytical changes
Performing technical review and approval of applicable BDS protocols and reports
Manage Change Control process and drive implementation of related tasks.
Providing SME support to the Manufacturing and Tech Services teams (inclusive of NPI projects for commercial product and new builds) which the company undertakes through project participation and QC readiness
Representing QC at product and technical team meetings and support all associated support activities
Supporting management in continual enhancement of the QC strategic plan
Drive process efficiencies and develop CI capability, using CI tools to drive and support improvements within QC with a particular focus on new technologies
You will need to have:
B.Sc. degree in biological /chemical sciences, business, or other related technical degree or equivalent experience in regulated industry
Preferable 4-6 years’ experience in quality control / cGMP Quality environment in a biotech, pharmaceutical or bio-pharmaceutical manufacturing environment
A high degree of technical competency in Chemistry and Biochemistry methos
Demonstrated ability to successfully collaborate, influence and lead in a matrix organization
Excellent communication and interpersonal skills
Proven record in demonstrating agility
Experience of involvement in technical issue resolution, in a multidisciplinary environment
We would prefer for you to have:
Experience in writing of technical documents and investigations
Project management skills.
High level of proficiency in MS Office software including: Word, Excel, Outlook, Visio, and PowerPoint.
Date Posted
26-Nov-2025Closing Date
25-Dec-2025Our 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.