Job Description
Here at Hays, we have a fantastic opportunity with our client, a research-based biopharmaceutical company. This would be a long-term contract position with an industry name that specialises in the discovery, development, and commercialisation of innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, they seek to improve the care of patients living with life-threatening diseases around the world. Their main therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. Your new role Complies with the responsibilities of a Qualified Person (QP) stated in directives issued by EC. Certifies batches for sale or supply in compliance with regulations. Approves Annual Product Quality Review, SOPs, Complaint investigations, Deviations (EQMS general investigations). Attends and participates in Event Review, Quality Systems Review and Site QP Meetings Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements. Participate in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed to ensure defined quality objectives are met. Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs). What you'll need to succeed Demonstrates excellent verbal communication, technical writing and interpersonal skills. Demonstrates working knowledge with good proficiency in Microsoft Office applications. Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistics is beneficial. Working knowledge of risk management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial. Must meet the minimum requirements for education and experience as outlined in Directive 2001/83/EC relating to medicinal products for human use. Some years of relevant experience in the pharmaceutical industry and a BS or BA or relevant experience and an MS. What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career. Hays Ireland is a trading division of Hays Specialist Recruitment (Ireland) Limited and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C's, Privacy Policy and Disclaimers which can be Skills: Batch release Qualified Person QP qualification Secondary Packaging Benefits: Contract role