Qualified person

The Client My client is a manufacturer of Veterinary products based in Co Kerry. They have been a market leader in their industry for over 30 years with a first class manufacturing suite. We are currently recruiting a Qualified Person to join their senior team on a hybrid basis. The Role Ensuring that an effective pharmaceutical Quality Management system is operated and that all regulatory obligations of the manufacturing authorisation holder are fulfilled Being responsible for disposition of medicinal veterinary product Manage communications with and represent the company during Regulatory Inspection. Support Regulatory inspections and prepare written responses to inspections. Prepare and approve Regulatory variations. Support internal compliance audits of operations. Oversee the team in the review and approval of Non-Conformances (NC), CAPA, change controls and complaints. Ensure Batch record review to verify compliance with GMP and Market Authorization prior to batch release. Assist in the preparation, review and regular update of technical agreements with licensees and 3rd party contractors. Organise and schedule periodic review of QMS and operational procedures for regulatory compliance through internal audit system. Participating in cross functional teams as Qualified Person representative Providing advice and direction to other company departments on quality and regulatory issues Apply high ethical standards and professional conduct with clients and with Authorities The Person Experience in sterile manufacturing at an MIA site A relevant third level qualification in Science or equivalent The QP must be eligible to act as a European Qualified Person (QP), certifying products in compliance with 91/412/EEC , EU2019/6 & Annex 16. Next Steps To apply for this position please click the link to send your CV, or call Seamus at SEDA Talent on for more details.