Job Reference: J5635251
Updated On: 09/07/2021
Status: Now Interviewing
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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 under EU Directive 2001/20/EC for the release of batches imported to or processed, fulfilling the requirements specified in Article 13.3 and undertaking the duties outlined in Annex 13.
2) Determine the requirements for, and level of release necessary for materials handled, including the release of just-in-time labelled material for despatch.
3) Evaluate study supply chains and assess, as applicable, each site involved to ascertain compliance with standards at least equivalent to EU GMP. Audit manufacturing and testing sites as well as compiling audit reports to a high standard in accordance with the relevant procedure.
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 be appointed as Qualified Person under the permanent provisions to our client's license.
2) Experience in undertaking the routine duties of a Qualified Person as well as releasing clinical products.
Key Words: Qualified Person / QP / Quality Assurance Professional / Batch Release / GMP Quality / Quality Assurance / Contract
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