Job Reference: J5633492
Updated On: 11/08/2020
Status: Open to Applications
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Role OverviewWe are currently looking for a permanent Qualified Person / QP to join a leading Biopharmaceutical company, based in the Wiltshire area. This exciting opportunity is ideal for a Qualified Person who is currently named on a Manufacturing Licence and who wants to further develop their career in an aseptic biotechnology working environment.
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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