Job Title

RRxCo has been exclusively retained by an exciting and growing pharmaceutical company to help them find the next QP. Read all the information about this opportunity carefully, then use the application button below to send your CV and application.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 companys 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 CMOsDeliverables: 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 programmesImplementation of best practices to ensure GMP compliance for all products marketedTo perform internal and external audits (including manufacturer, packaging and suppliers' sites) and supporting authority inspections as requiredInvolvement with technical customer queries and product investigations as requiredCo-operation and communication with internal and external customersPlanning and coordinating the implementation of any new legislative regulatory requirements in a timely fashionIn conjunction with the Regulatory department,t manage the relationship with MHRA regarding quality issues, batch recalls, and requests for informationCompletion of QP declaration and management of Quality functions around APIsReview 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 reportsReview CMO batch records, analytical C of A to a high level in or to perform batch certification in accordance to all aspects of EU guide Annex 16Ensuring 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 checked, and tests have been performed In line with manufacturing procedure, including review and approval of laboratory investigation reportsMaintenance of a register as a record of product batches that have been certifiedOffering 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 requirementsPerformance 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 organisationWriting, reviewing, updating and approving of Standard Operating Procedures. Providing training to employees as require, to increase understanding of regulatory GMP requirements and that training records are maintained as per business requirementsThis is an urgent role so for full details please get in touch as soon as possible.