Job Reference: J5634721
Updated On: 06/04/2021
Status: Open to Applications
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Role OverviewThe role of the Qualified Person is integral to the success of the Quality Department in delivering expert advice and ensuring release of clinical supplies, in line with customer expectations and regulatory demands. The Qualified Person will ensure that finished products are not released until their quality has been judged to be satisfactory as measured against specifications and regulatory requirements.
Key Duties and ResponsibilitiesThe duties of the Qualified Person / QP are broad and a detailed job description is available on request.
An example of such duties include:
1) Act as a Qualified Person releasing Investigational Medicinal Products (IMP) as per Clinical Trial Regulations 2004.
2) In your role as the Qualified Person, you will have a sound understanding of cGMP and cGCP standards, and be able to advise on issues that may arise.
3) You will take the lead in helping the company obtain their UK MIA (IMP) Licence.
Role RequirementsThe successful Qualified Person / QP will need to demonstrate the following in their profile to be considered:
1) Degree in a relevant scientific discipline and be eligible to act as an MIA (IMP) QP and be named on MIA (IMP) Licence.
2) Experience in undertaking the routine duties of a Qualified Person as well as experience in auditing suppliers.
Key Words: Qualified Person / QP / Quality Assurance Professional / Batch Release / Quality Assurance / Contract / IMP / Clinical Trials
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