A Qualified Person is required for a research-based, market leading, top Ten Biopharmaceutical company based in Cork for a 12 month contract. The Cork campus specialises in Tabletting, Solid Dose, Packaging & Distribution of a range of product and is strategically important site within their global operations and has grown consistently since its founding almost 15 years ago.
As QP you will :
o Comply with the responsibilities of Qualified Person (QP) stated in directives issued by EC.
o Certify batches for sale or supply in compliance with regulations.
o Approve Annual Product Quality Review, SOPs, Complaint investigations, Deviations (EQMS general investigations).
o Attends and participates Event Review, Quality Systems Review and Site QP Meetings
o Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
o Participate in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed to ensure defined quality objectives are met.
o Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
As QP you will
o Meet the minimum requirements for education and experience as outlined in Directive 2001/83/EC relating to medicinal products for human use QP on a manufacturing license preferable
o Some years of relevant experience in the pharmaceutical industry and a BS or BA.
o Or some years of relevant experience and a MS.
o Proficient in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
o Proficient in application of QA principles, concepts, industry practices, and standards.
o Demonstrates ability to effectively manage multiple projects/priorities.
o Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.
For full details of this role please contact Kathy on 021 4777329 or apply directly through this advert.