Company Overview
{company} is a renowned manufacturer of Veterinary products based in Co Kerry.
With over 30 years of experience as a market leader in their industry, they boast a first-class manufacturing suite and a commitment to excellence.
The Role
* Ensure the effective operation of a pharmaceutical Quality Management system and fulfill regulatory obligations of the manufacturing authorisation holder.
* Be responsible for the disposition of medicinal veterinary products.
* Manage communications with and represent the company during Regulatory Inspections.
* 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 systems.
* Participate in cross-functional teams as Qualified Person representative.
* Provide advice and direction to other company departments on quality and regulatory issues.
* Apply high ethical standards and professional conduct with clients and 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.
Key Responsibilities
This role offers a unique opportunity to work with a leading Veterinary product manufacturer, contributing to the development of innovative solutions that drive excellence in animal health. If you are a motivated and experienced professional looking to take your career to the next level, this could be the ideal position for you.