Quality Assurance Advisor

We are, on behalf of one of our customers, looking for a Quality Assurance Advisor.


Assignment Description -
In your role you will have interactions with internal and external stakeholders.
• Provide QA advice into manufacturing activities of Drug Product and patient medication
• Perform QA release of manufactured and packed Drug Product as part of the Supply Chain to clinical trials
• Support the pharmaceutical development functions with investigations of deviations, complaints, changes and other quality and compliance decisions in the development projects
• Provide appropriate QA input to business improvement projects
• Collaboration with AstraZeneca QA colleagues globally
• Responsible for QA advice and approval of documentation related to manufacturing equipment and facilities to ensure compliance, including Maintenance, Calibration, Validation


The role may also include
• Interpret, trend and report compliance data, to measure and improve quality standards within the pharmaceutical development functions.
• Develop QA Agreements with internal suppliers delivering services or products.


Minimum requirements –
• MSc in pharmacy or engineering (specializing in Pharmaceuticals) with at least 3 years’ experience of working within a pharmaceutical GMP environment
• Broad understanding of the Pharmaceutical Quality Systems, GMP and related activities to Investigational Medicinal Product (IMP)
• Comprehensive understanding of the pharmaceutical/drug development process
• Good communicator with experience of interacting effectively across interfaces
• Fluent in written and spoken English


Preferred requirements
• Experience preferably within a pharmaceutical manufacturing organization
• Good team working and networking skills
• Capable of making effective decisions
• Demonstrate a high degree of personal credibility