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My client are seen as one of the top ten global biotechnology companies to watch in 2020, who have real focus on the development and commercialisation of unique gene therapies to change lives. They have a strong pipeline with two clinical trials ongoing and two more coming in 2020 which allows them to have a real chance to change the lives of patients by providing directed gene therapy as a life long and potentially curative treatment. This company are fully invested into their employees by providing professional development, flexible work/life balance and a chance to make a real-world impact.
In this opportunity you will be reporting to the VP of Quality Assurance where you will be focusing on the GMP manufacture and release of products for clinical supply. You will be given the freedom to implement strategies to allow a continuous improvement environment which can be in relation to manufacturing, SOPs, GMP documentation, Quality related issues etc. Furthermore, you will be responsible for assisting/providing GMP & GDP training to staff to ensure all are working to the correct procedures.
Prior knowledge to quality supporting documentation to facilitate GMP production.
Review of GMP manufacturing/batch records.
Write and revise quality SOPs, implement new strategies to allow a continuous improvement environment.
Release documents and labels to the manufacturing/production teams.
Will lead/co lead on staff training for GMP & GDP.
Primary point of QA contact at the manufacturing site for GMP deviations and change control assessments.
Assist with validation / qualification activities as directed by QA director.
Bachelor's degree in the biological sciences or related field.
Prior experience in the pharmaceutical/biotechnology industry, minimum 2-3 years QA GMP experience in a biotech, pharma or biologics operation.
Knowledge of Quality Management System elements and experience in maintaining and improving systems.
Working knowledge and ability to apply GMPs in conformance with FDA, MHRA, EU and ICH standards, preferably gained from working in a manufacturing or QC environment.
Internal/external auditing would be ideal.
If you are looking to share an ambition of excellence and you are looking for a high paced work environment, this could be a perfect fit for you.