Negotiable
Inside
Hybrid
Macclesfield, England, United Kingdom
Summary: The Quality Assurance Specialist role based in Macclesfield, UK, involves ensuring the QA release of Drug Substance and Investigational Medicinal Products for clinical trials. The position requires a minimum of three days per week in the office, emphasizing collaboration and flexibility. The specialist will also support the development and improvement of GMP quality systems across various projects. This role is part of a diverse and inclusive team committed to making a meaningful impact on patients' lives globally.
Key Responsibilities:
- Responsible for QA release of Drug Substance and Investigational Medicinal Product for clinical trials.
- Provide input to support Packaging, Labelling & Distribution of IMP as required.
- Support the delivery of QA activities for assigned portfolio of projects.
- Provide advice to support the development, implementation, and continuous improvement of GMP quality systems.
- Support implementation of agreed global standards.
Key Skills:
- Appropriate scientific degree with 2-3 years of experience in a pharmaceutical GMP/GCP environment.
- Broad understanding of Quality Systems and GMP.
- Understanding of the pharmaceutical/drug development process.
- Experience in Change Controls/Deviations/Batch Release is preferable.
Salary (Rate): undetermined
City: Macclesfield
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: inside IR35
Seniority Level: undetermined
Industry: Other
Location – Macclesfield, UK Hybrid Working - Min 3 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 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.