Commercial Qualified Person CQP

Cordant People ,
Ebbw Vale, Gwent
More Details
Job Type: Full-time
Salary: £85,000 per annum

Overview

Here at Cordant People we are currently recruiting a Commercial Qualified Person to be a key member of one of our clients team based in the Ebbw Vale area. This position is in the Pharmaceutical industry so previous experience in this sector is vital. The CQP certifies finished products for commercial distribution and investigational medicinal products. The CQP has the responsibilities defined in EU Directive 2001/83/EC. The QP ensures that a batch is in accordance with the relevant requirements as defined in Eudralex Volume 4 and the marketing authorisations. Duties and Responsibilities: CQP legal responsibilities are defined in EU directive 2001/83/EC and in the EU GMP Guidelines Eudralex Volume 4, especially Annex 16. Certifying batches for sale or supply (in compliance with the regulations) Assessing compliance of each batch with the packaging specification, Customer Quality and Technical Agreements, European current Good Manufacturing Practice and the Marketing Authorisation (where applicable, e.g for products released to market) Maintaining an active involvement in driving site GMP compliance and providing QP Guidance to the site and training and development in GMP and related issues Annual Product Quality Reviews Keeping relevant Standard Operating Procedures up-to-date Quality Agreements The CQP has a joint responsibility with QA for: The management of individual elements of the companies Quality Management Systems which include: o Customer complaints o Deviations o Supplier complaints o CAPA o Change control o Supplier and internal auditing o Regulatory and customer auditing o Generating KPI's Operations support and QC support for quality-related operational issues The Commercial QP is the primary contact person for the inspectorate and regulatory authorities regarding GMP. The Commercial QP is one of the key contacts for Recalls. Skills: Excellent planning & organising skills, accuracy and attention to detail and an ability to create a positive impact and convey confidence and credibility to others. The ability to produce results, prioritise their objectives and schedule work to make best use of time and resources with a sound understanding of the commercial implications of role. Must be able to cope effectively with pressure and setbacks and maintain commitment. Must undertake stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels. Essential: A 3rd level Pharmacy degree qualification or equivalent Approved QP status and eligibility for the QP role Evidence of Continuous Professional development desirable Minimum 5 years relevant experience in the pharmaceutical industry in particular of which 3 years are in a Qualified Person role Sound experience of pharmaceutical production, especially primary and secondary packaging In depth understanding of GMP and QA systems are essential including interpreting current regulatory requirements. High level of spoken and written English. Leadership skills If you have all the skills above and feel this role could be for you then we would love to hear from you So please apply Due to the high volume of enquiries that we receive, we are not always able to respond to all CV's. If you have not received a response within two weeks of applying, please assume your application has been unsuccessful. Good Luck with your application and we look forward to receiving your CV. Cordant Group is an equal opportunities employer

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