Job Reference: J5634439
Updated On: 18/02/2021
Status: Open to Applications
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Qualified Person
Salisbury, WiltshirePermanent
£75,000 per annum
Sectors: Pharmaceutical
Skills: Quality Assurance - Qualified Person - Permanent, Quality Assurance - Permanent, Quality Assurance - GMP, Quality Assurance - Compliance, Quality Assurance - Auditing, Quality Assurance - Biologics
Skills: Quality Assurance - Qualified Person - Permanent, Quality Assurance - Permanent, Quality Assurance - GMP, Quality Assurance - Compliance, Quality Assurance - Auditing, Quality Assurance - Biologics
Job Information
Role Overview
We 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 Responsibilities
Your 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 Requirements
To 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
Your Recruitment ConsultantChris Careychris.carey@hyperec.com
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.
