- East Anglia
- Non-Laboratory & Other Scientific Roles
About this job
Unique opportunity to join an innovative drug discovery and development company as Quality Assurance Manager, maintaining high GxP standards and ensuring the upkeep of secure and organised archives.
With a client base ranging from virtual biotech companies to multinational pharmaceutical companies, this position will be the primary source for quality assurance in the company, maintaining and training staff to GLP and GCP, and coordinating and completing audits.
You will be additionally responsible for the archives, ensuring all GxP documentation is received and processed securely into the archives with easy retrievability, alongside managing the company’s biobank. You will need to liaise effectively with the QA consultant for additional auditing and archiving processes, as well as arranging an effective audit schedule with the Test Facility Management.
- Knowledge of GLP and GCP is essential
- Knowledge of GMP is desirable
- Previous experience interacting with regulatory bodies (MHRA, FDA)
- Knowledge of auditing principles and practices
- Understanding of Data Integrity guidance and knowledge of computerised system validation (CSV)
Apply today or get in touch for more information.
Keywords: quality assurance, QA, quality manager, GCP, GLP, good clinical practice, good laboratory practice, GCLP, GxP, cGxP, clinical phase, drug discovery, quality officer, audit, CAPA, change control, deviation, investigations, archives, digital archives, MHRA, FDA, biobank, CSV, computerised system validation, Cambridge, Cambridgeshire, East Anglia, VRS7882BH
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