About Your New Employer
My client is the world leader in delivering first-in-class therapies for rare genetic diseases.
They are now hiring a QA Associate to join their ever-growing team for a 23-month contract.
Operating across 4 continents they have an appetite for science, which drives them to provide life-changing results for their patients worldwide.
They have a skilled workforce that is collaborative, curious and shares a passion for shared accomplishments.
About Your New Job
- Assist with quality oversight of the supply chain, manufacture, and packaging of products in various Contact Manufacturing Organizations.
- Review of Manufacturing/Packaging batch records and Quality Control documentation prior to recommending final batch release.
- Review and approve standard operating procedures, master batch records and product specifications.
- Provide Quality oversight of deviation and investigation reports.
- Proactively support the continuous improvement of quality systems.
- Assist with periodic audits and reviews of contract manufacturers.
- Artwork review and approval.
- Assist with new market launches.
- Support quality deviations, change controls, validation activities, audits internal & external, annual product reviews, and external customer complaints activities as needed.
What Skills You Need
- Level 8 honours degree in of Sciences (BSc) degree, or higher, in a technical discipline.
- 5+ years of experience in a cGMP regulated FBDS, drug product manufacturing and/or packaging environment is a pre-requisite for application, with exhibited knowledge or proficiency in Quality Assurance and Compliance.
- Ability to comprehend technical information related to equipment, manufacturing processes, and regulatory expectations
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
What's On Offer?
- Full time – 39 hours p/w – 23-month contract.
- 25 days annual leave.
- Salaried – monthly paid.
- For a confidential discussion on this or any other current job opportunity please contact Meggan Tully on firstname.lastname@example.org.
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