QA Project Specialist
- Contract Type
QA Project Specialist
6 month contract with potential to extend
The role is within the Quality Assurance organisation and is based in Berkshire.
Dependent on the experience of the candidate, the scope of the role would involve process validation, analytical validation, technology transfer, stability studies, comparability studies, shipping qualification and cell line characterisation in accordance with FDA and EMEA requirements.
The role entails working closely with scientists, regulatory affairs and QA, internally and with contract manufacturers, to provide advice, support, and troubleshooting on the studies to be performed.
A key component of the position is the review and approval of project documentation, such as protocols and reports, to ensure that the required regulatory and quality standards are met. The review will include a high level of data verification, requiring the ability to assimilate complex project scenarios and drive the project program forwards with said focus on regulatory and quality requirements. The candidate will also be required to provide the QA input for assessment and documentation of investigations, deviations and change controls, and review of batch manufacturing records to support the release of batches for clinical and commercial use.
The candidate must be experienced in the pharmaceutical biologics industry with an understanding of the applicable regulatory requirements for development of therapeutic monoclonal antibodies in an analytical capacity and/or in process development or manufacturing, and experience of working to GMP standards. Experience of working in GMP QA is highly desirable.
The candidate must be an excellent communicator, able to work both as part of a team and independently, with proven ability to meet timelines and work under pressure, and apply high standards to their work with close attention to detail. Demonstrable evidence of complex project management within a QA context is highly desirable.
5 - 10 years experienced professional in biotech/pharma
Option for home based 1 day per week after initial period of time
Ideal start 2nd January '19
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