Qualified Person (QP)

RRxCo has been exclusively retained by an exciting and growing pharmaceutical company to help them find the next QP. This role is only suitable for candidates who are already qualified as a QP and can be in the Greater London (west) office weekly. Although it will be a hybrid position.

The Qualified Person is instrumental in performing the release activities for the company and leading batch assessments to ensure releases are carried out efficiently, in a timely manner and meeting relevant quality and regulatory standards. Maintaining compliance with the company’s GMP Quality Management System, manufacturing authorisations, all relevant UK/ EU regulatory and legislative requirements with the Quality Assurance (QA) activities.

Management of queries relating from QP batch review internally and other CMOs.

• Activities as a Qualified Person in quality control and batch release of pharmaceutical products manufactured and tested by CMO and 3rd party laboratories.
• Promoting compliance and adherence to Quality Policies, Standard Operating Procedures (SOPs) and training programmes.
• Implementation of best practices to ensure GMP compliance for all products marketed.
• To perform internal and external audits (including manufacturer, packaging and suppliers' sites) and supporting authority inspections as required.
• Involvement with technical customer queries and product investigations as required.
• Co-operation and communication with internal and external customers.
• Planning and coordinating the implementation of any new legislative regulatory requirements in a timely fashion.
• In conjunction with the Regulatory department, manage the relationship with MHRA regarding quality issues, batch recalls, and requests for information.
• Completion of QP declaration and management of Quality functions around APIs.
• Review of any quality-related documentation associated with batch certification process, including but not limited to AMTS, Validation, audit report, OOS reports, TSE/BSE and Nitrosamine reports.
• Review CMO batch records, analytical C of A to a high level in order to perform batch certification in accordance to all aspects of EU guide Annex 16.
• Ensuring any deviations in CMOs manufacturing, quality procedure are managed and notified in accordance with the defined reporting system before any product is certified.
• Approval of CMOs manufacturing change controls and ensuring compliance to the regulatory dossier.
• Ensuring that the necessary quality control checks and tests have been performed in line with manufacturing procedure, including review and approval of laboratory investigation reports.
• Maintenance of a register as a record of product batches that have been certified.
• Offering advice and guidance with respect to regulatory expectations and recognised best practice.
• Reviewing technical agreements on behalf of the business, in line with the Product Launch Managers requirements.
• Performance of recall and Mock recall ensuring records are effectively maintained to help manage this process when required.
• Helping to improve the quality management system and its maintenance, promoting and helping in the continued development of a quality culture throughout the organisation.
• Writing, reviewing, updating and approving of Standard Operating Procedures.
• Providing training to employees as required, to increase understanding of regulatory GMP requirements and that training records are maintained as per business requirements.

This is an urgent role so for full details please get in touch as soon as possible.