Job Reference: J5635403
Updated On: 24/08/2021
Status: Open to Applications
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Role OverviewWorking in partnership with a pharmaceutical manufacturing site, we are looking for a Qualified Person who would be interested in a permanent opportunity.
The business operates as a CDMO, so it is fast paced, and client focused. As the QP, you will have a vast amount of client interaction, will work with multiple dosage forms and support wider Quality improvements.
The site is building a new sterile manufacturing facility, with a go date live of H2, 2022. As a named QP, you will work to support the implementation of the Quality System, and will then release sterile products.
Key Duties and ResponsibilitiesYour duties as the Qualified Person will be varied however the key duties and responsibilities are as follows:
1. Undertake the duties of a Qualified Person as defined in Directives 2001/83/EC as amended and 2001/20/EC responsible for recording batches released in the QP Register.
2. Responsible for review of relevant documentation associated with the manufacture and testing of Drug Substance and Drug Product Intermediates, as well as being responsible for the QP certification of Drug Product Intermediates in accordance with UK Code of Conduct for Qualified Persons..
3. Act as a GMP Subject Matter Expert (SME) to facilitate site compliance with the company’s Pharmaceutical Quality System (PQS) and support senior QA leadership through QP decision making to drive continuous improvement and ‘fitness for purpose’.
Role RequirementsTo be successful as the Qualified Person / QP we must identify the following on application:
1. Certified / registered Qualified Person with a degree in a relevant science discipline (i.e chemistry, biotechnology, quality management etc) plus proven industry experience as a QP named on a manufacturing licence.
2. Previous GxP, QMS process design / implementation / management / utilisation, auditing and project management experience
Key Words: Qualified Person | QP | Commercial batch release | GxP | compliance | MHRA | Batch release | GMP | Sterile | Aseptic | QA | Quality Assurance | QMS
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