- South East
- £Highly competitive
- Non-Laboratory & Other Scientific Roles
About this job
Career defining opportunity for a driven and highly experienced QA Specialist to join a world-renowned expanding biological research laboratory!
Working in support of the operational QA team you will provide advice and support for a variety of late stage biological development projects including; drug substance and product development, tech transfer and manufacture. Your primary responsibilities will include the approval and review of a broad range of technical documentation from manufacture and tech transfer protocols through to process development studies, batch documentation, deviations, change controls and CAPA. You will ensure compliance to regulatory guidelines e.g. GMP and document consistency.
The successful candidate will possess a minimum of 7 years’ experience in the pharmaceutical biologics industry in a QA focussed position as well as having experience in one or more of the following:
- Regulatory submission preparation for biological products
- ICH Q2 analytical method validation principles and general analytical techniques
- GMP process validation experience
- Drug product /substance process manufacture for biological products
Apply to VRS today to be considered for this highly rewarding position!
Please note: this position is offered initial on a 12-month contract with possibility for extension /become permanent
Key Words: QA, Quality Assurance, Quality Specialist, Drug Development, Biologics, Drug Substance, Drug Product, Technology Transfer, Process Development, Process Improvement, SOPs, Change Control, Deviations, Regulatory Guidelines, GMP, Good Manufacturing Practice, Technical Documentation, Pharmaceutical, South East, Berkshire, Slough, VRS6705HQ
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