Qualified Person QP

1 day ago

Tralee, Ireland Ballinskelligs Veterinary Products Full time

THE ROLE: Option for hybrid. Ensuring that an effective pharmaceutical Quality Management system is operated and that all regulatory obligations of the manufacturing authorisation holder are fullfilled Being responsible for disposition of medicinal veterinary product Collaborate with the General Manager, Production Manager and Quality Manager in order to achieve and maintain Quality and Compliance standards. 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. Escalation of issues as appropriate. 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 Requirements: Minimum of 1 years 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. Benefits: Company pension On-site parking Sick pay Skills: QP Veterinary Product Product Release GMP Pharma Manafacture Benefits: Pension Fund Parking

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