This organisation is a globally renowned leading healthcare company, with a focus on developing revolutionary therapeutics that have a meaningful impact on patients' health worldwide. With over 70,000 employees worldwide and a total revenue of $40 billion in 2017, this company is passionate about finding solutions and treatments for some of the world's most challenging healthcare needs. They are continuously expanding in Ireland and have recently undertaken investments of over €300 million. Due to the continued growth of the company in Ireland, a role has arisen for a Senior Quality Specialist to be based at their state-of-the-art facility in Cork
The Senior Quality Specialist will;
- Perform EQA releasing of sterile products, manufactured at Contract Manufacturing Organisations (CMO) to downstream site with the assurance that the goods were manufactured in conformance with all applicable policies / procedures and in compliance with all governing Regulations.
- Be responsible for implementing Quality Control policy supporting the compliant supply of product by external manufacturers of sterile pharmaceuticals / biologics, by means of a risk based quality oversight, on site quality support and technical advice, counselling of manufacturing site senior leadership and providing routine on-site supervision as appropriate.
- Review the executed batch records and ensure that the product has been produced in compliance with the approved batch record instructions and follow up and ensure timely close out of all corrections associated with the Batch Record Review.
- Co-ordinate the full investigation into all Customer Complaints received for any of the batches manufactured by the CMOs.
- Contribute to EQA Management Operational and Strategic Initiatives.
You will have a minimum of 3 years' experience, with previous experience in a Quality Assurance / Compliance role. A BSc in Science, Engineering or an equivalent discipline is required.
This position offers an excellent remuneration package, along with superb working conditions and the option of working remotely.
To learn more, apply online or call Paul Wheatley on +353 21 4511190 for a confidential discussion.