Our client is an independent contract development manufacturing organization who specialize in the innovative development of new entities for biotech companies.
They are currently looking for two QA officers to work within their Project Lifecycle Group, you will work closely with many other departments from Production, Product Development and Quality Control.
What You’ll Do:
- Performing quality assurance of stability data to support shelf life of products in clinic.
- Preparation and QA review of batch dossiers and product specification files to support QP release of products to clinic.
- QA review of change controls including shelf-life extensions for products in clinic.
- Providing Quality guidance and support in laboratory investigations, deviations, change controls, quality improvements, customer and supplier complaints.
- QA review of updates to finished product specifications, IPC specifications, analytical methods, SOPs and stability protocols.
- Come from a pharmaceutical or scientific background, preferably with a degree in a scientific or pharmaceutical discipline
- Have a strong understanding of Good Manufacturing Practice (GMP) and it’s application in Medicinal and commercial products.
- Experience or knowledge of the transfer of new products into clinical manufacture would be preferred.
- Prior experience within a QC or QA role would be preferred.
- Be able to cope with a tight timelines, be resilient and able to find solutions to problems as and when they arise.
On this occasion LiCa Scientific is acting as an employment agency.
- Quality Assurance
- Shelf Life
- Product Specification
- Scientific Background
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