We are proud to be partnered with fast growing UK based Biotech company wo are seeking a GCP QA Manager.
Are you a Quality Assurance Specialist with good knowledge of GCP & GMP?
· Supporting the Director of Quality in the management of the QMS
· Ensure the company maintains ‘Inspection Ready Status’ at all times
· Managing the clinical audit programme
· Performing internal, CSP and clinical site audits
· Key Essential Document audits, including Investigator’s Brochure, Clinical Protocols and Clinical Study Reports
· Managing independent auditors.
· Supporting and deputising for the Director of Quality
· Ensuring compliance with GCP and other regulatory requirements.
Qualifications and/or experience required to perform the role
· Four years’ quality assurance experience in a pharmaceutical or Biotechnology organisation
· At least two years’ experience as a Clinical Quality Assurance Associate/Auditor
· Scientific degree
· Good experience of auditing suppliers and clinical investigator sites
· Detailed knowledge of GCP is mandatory
-Company and individual bonus
-4 x Life Assurance upon death whilst employed
-Medical Cover with previous medical history disregarded
-Pension – up to 5% matched by company
-Stock options – tbc the amount and pricing
-25 days leave per year plus bank holidays