Qualified Person

Life Science Consultants Ltd

Cork

A Qualified Person required for a market leading, top Ten Biopharmaceutical company based in Cork . The Cork campus specialises in Tabletting, Solid Dose, Packaging & Distribution of a range of products. The site is a strategically important site within their global operations and has grown consistently since its founding almost 15 years ago. Today the site is responsible for Tablet manufacturing, quality control, packaging, and the release and distribution of the company's products in the EU and other international locations. The Cork campus is a team focused organisation, who work to ensure their medicines are delivered on time and to the highest possible quality. In this new position the Qualified Person will: Comply with the responsibilities of Qualified Person (QP) stated in directives issued by EC. Certifies batches for sale or supply in compliance with regulations. Release Investigational medicinal Products in accordance with the requirements of Annex 13. Approve Annual Product Quality Review, SOPs, Complaint investigations, Deviations (EQMS general investigations. Attend and participates Event Review, Quality Systems Review and Site QP Meetings. Perform 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. Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs. Review manufacturing, environmental monitoring and quality control data for in-process and finished products. The Qualified Person will require: Proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs). Proficient in application of QA principles, concepts, industry practices, and standards. Demonstrates ability to effectively manage multiple projects/priorities. Proven analytical and conceptual skills. An understanding of international quality systems regulations to adopt best in class systems/processes. Excellent verbal communication, technical writing and interpersonal skills. Working knowledge with good proficiency in Microsoft Office applications. Knowledge of Six Sigma, Define-Measure-Analyse-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical 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 a MS. Contact Kathy at LSC on 021 4777 329 for more detailsabout this Qualified Person role, or apply directly via this advert. This job originally appeared on RecruitIreland.com.

2791 days ago