AstraZeneca Quality Assurance Advisor - through KellyOCG
KellyOCG Sweden AB / Kemiingenjörsjobb / Göteborg
2024-09-10
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hela Sverige AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development, and commercialization of prescription medicines for some of the world's most serious diseases.
KellyOCG is working closely with AstraZeneca to find a new Quality Assurance Advisor with GMP focus to their Gothenburg / Mölndal team. This is initially a one-year contract with KellyOCG, with possibility for extension and future roles in the AZ organization. You will be an important, fully integrated member of the AstraZeneca team, reporting to your manager on-site.
The arena
Are you interested in a challenging opportunity within the Development Quality function in one of the world's leading pharmaceutical companies?
The Development Quality function is responsible for quality oversight of the pharmaceutical development activities in AstraZeneca. The organizations pharmaceutical development organizations manage all facets of the process of turning a molecule into a medicine which can be safely and effectively used by patients. The Quality Advisor role has a broad range of responsibilities to ensure all internal and external requirements are fulfilled for the AstraZeneca projects in the development phase.
The role
As a Quality Advisor, you will work with early product development manufacturing and packaging teams and be responsible for Development Quality release of externally manufactured Drug Product and Investigational Medicinal Product for clinical trials. You are expected to assure that activities and processes across the development chain are delivered to appropriate standards to meet regulatory expectations and assure product integrity and acceptability.
You will develop and maintain a knowledge of the quality regulations and guidelines applicable to your area and a deep scientific understanding of the products that you are supporting. In your role you will have interactions with internal and external stakeholders.
Typical Accountabilities:
• Responsible for quality Release of manufactured Drug Product, Investigational Medicinal Product for clinical trials.
• Providing quality input to Manufacturing, Packaging, Labelling & Distribution activities.
• Providing proactive quality advice to support the development, implementation, and continuous improvement of GMP quality systems across the Clinical Supply functions and support implementation of agreed global standards.
• Support the pharmaceutical development functions with investigations of deviations, changes and other quality and compliance decisions in the development projects.
• Provide appropriate Quality Assurance input to business improvement projects.
• Operate as part of a global organisation with an integrated mindset to create an organisation with common processes and ways of working.
Requirements:
• Degree in pharmacy or engineering (specializing in Pharmaceuticals)
• 2-3 years' experience of working within a pharmaceutical GMP environment.
• Understanding of Quality Systems and GMP and related activities to Investigational Medicinal Product (IMP).
• Experience of documentation, deviations, changes, and other quality and compliance
decisions in the development projects.
• Experience preferably within a pharmaceutical manufacturing organization is desirable
• Understanding of Project Management processes is desirable
• Fluent in written and spoken English, Swedish highly meritous
Desirable:
• Good team working and networking skills.
• Capable of making effective decisions.
• Demonstrate drive and energy in the role to make a difference.
• Demonstrate a high degree of personal credibility.
• Comprehensive understanding of the pharmaceutical/drug development process.
• Good communicator with experience of interacting effectively across interfaces.
Please note that the recruitment process may be finalized before the application deadline, so early applications are encouraged. Apply through the link below.
Så ansöker du Sista dag att ansöka är 2024-09-24
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare KellyOCG Sweden AB (org.nr 559407-1622)
Arbetsplats AstraZeneca / KellyOCG Sweden AB
Jobbnummer 8891342