Quality Project Specialist - Biological Clinical Development

£40 to £60 per hour
08 Jun 2018
06 Jul 2018
Georgia St John-Smith
Contract Type
Full Time
We are currently looking for a Quality Project Specialist to join a leading Life Sciences company based in the Berkshire area.

As the Quality Project Specialist you will be joining a team working on the transition of a biological product from clinical development through to market launch.

Depending on your skill set, this role will involve; process validation, analytical validation, technology transfer, stability studies, comparability studies, shipping qualification and cell line characterisation in accordance with FDA and EMEA requirements.


Your duties as the Quality Project Specialist will be varied however the key duties and responsibilities are as follows:

1. You will be working closely with Scientist, Regulatory Affairs and QA, internally and with Contract Manufacturers to provide advice, support and troubleshooting on the studies to be performed.

2. A key component of the position is review and approval of project documentation. 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.

3. You will provide QA input for assessment and documentation of investigations, deviations and change controls, and review of batch manufacturing records to support release of batches for clinical and commercial use.

4. As the Quality Project Specialist, you will bring Pharmaceutical Biologics experience, with an understanding of regulatory requirements for development of therapeutic monoclonal antibodies in an analytical capacity and/or in process development or manufacturing.


To be successful in your application to this exciting opportunity as the Quality Project Specialist we are looking to identify the following on your profile and past history:

1. Relevant degree in a Scientific Discipline

2. Proven industry experience with Pharmaceutical Biologics and Quality / Analytical or Process Validation / manufacturing readiness.

3. A working knowledge and practical experience with biologics in clinical development.

Key Words: process validation / analytical validation / technology transfer / stability studies / comparability studies / shipping qualification/ cell line characterisation / FDA / EMEA / MHRA / biologics / biopharmaceutical / biological / project management / quality assurance / QA / clinical / clinical development

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.

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