Qualified Person (QP)
Hartley People
Waterford, Kilkenny
Our client, an industry leading Pharmaceutical company, is currently seeking a Qualified Person. This person will report directly to the QA Manager. Main duties: 1. To ensure that all products being released for commercial or for clinical trial purposes comply with the requirements of the Marketing Authorisation, or Clinical Trial Authorisation and have been manufactured according to the principles of GMP as per Directive 2003/94/EC. The role: 1. Compliance. · To ensure that all processes/stages in the manufacture, testing and packaging of products have been adhered to according to the cGMP/cGLP/Regulatory requirements. · To develop and improve quality systems by identifying areas for improvement (NVAA’s and key variances) and take corrective action as required to ensure continuous improvement in accordance with Company Continuous Improvement Process. · To review change proposals and related documentation for compliance with Regulatory approvals and GMP requirements. · To ensure that all work carried out is in compliance with the required standards conforming to company, cGMP, cGLPs, SOPs, regulatory regulations and guidelines, H & S and Environmental guidelines. 2. Documentation. . To review and approve batch documentation, investigation reports, change requests, SOP’s and qualification reports, ensuring they are completed right first time and in full in accordance with Good Manufacturing Practice requirements. 3. Customer Service. · To review and release batches according to shipment schedule ensuring all batches are in compliance with regulatory requirements. · To identify and make recommendations for improvements to the process within the overall Continuous Improvement Process of the Company. The Person: 1. Minimum of 5 years previous experience within the Pharmaceutical industry in a QA/QC/Compliance role. 2. Qualified Pharmacist or Graduate of Diploma in Pharmaceutical Manufacturing Technology or equivalent “Qualified Person” status as defined by E.C. Directive 2001/83. 3. Excellent knowledge of regulations and sources of regulatory information. 4. Excellent knowledge of company procedures, policy and standards. 5. Understanding of Production and Laboratory systems to effect judgement decisions consistent with business needs. 6. Excellent planning and organisational skills to ensure workload prioritisation and schedule adherence. 7. An understanding of internal/external customer requirements and an ability to respond promptly to needs. 8. Ability to work on own initiative to meet and exceed business objectives. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. If you meet the criteria for this position, we will provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your consent. For immediate consideration please call Eamonn on 051-878 813 or email eamonn@hartleypeople.com wiith your CV in response to this job posting.
2829 days ago