Quality Assurance Specialist
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Location – Macclesfield, UK
Hybrid Working - Min 3-4 days per week in HQ
Duration – 12 months
Inside IR35
Make a more meaningful impact to patients’ lives around the globe
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three 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 this role you will be responsible for QA release of Drug Substance and Investigational Medicinal Product for clinical trials. Provide input to support of Packaging, Labelling & Distribution of IMP as required. In addition, you will support the delivery of QA activities for their assigned portfolio of projects and provide advice to support the development, implementation and continuous improvement of GMP quality systems across the development functions and support implementation of agreed global standards.
Essential Criteria
Appropriate scientific degree with experience (2-3 years) of working within a pharmaceutical GMP/ GCP environment, preferably within a pharmaceutical development organisation
A broad understanding of Quality Systems and GMP is essential
An understanding of the pharmaceutical/drug development process
Preferable have experience in Change Controls/ Deviations/ Batch Release
Ideally - experience with development products
IMP experience preferred
Desirable
- Computer System Validation experience
- Supplier Manager experience from a quality assurance perspective
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
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 from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Closing Date for Advert - Monday 18th May - Applications will be reviewed From this date