Position Details

Eduction
At least equivalent to a L8 course in a scientific discipline & have successfully completed a recognised post-graduate course in Ireland that satisfies the educational requirements as defined in the Veterinary Medicinal Directive 2019/6 for example Masters in Pharmaceutical Science/QP.

Experience

-Relevant pharmaceutical experience in compliance with Article 97 Veterinary Medicinal Directive 2019/6, & fulfil the conditions required to act in the capacity of QP.
-Experience as a named QP for a licensed facility preferable.
-Application of cGMP to manufacturing & testing.
-Technical & compliance-based writing skills.
-Experience in supporting inspections & internal audits.
-Demonstrated stakeholder management & escalation experience.

Skills
-Autonomy, self-motivation & efficiency with an appropriate sense of urgency in a fast-paced & dynamic environment.
-Strong verbal & written skills with ability to explain complex, challenging issues in a clear manner to all levels of the organization, especially management.
-Strong interpersonal skills, including diplomacy & flexibility, the ability to engage & influence effectively with key stakeholders.

Responsibilities 
-Ensure each commercial batch has been manufactured, tested & checked in compliance with Irish law following the requirements of the relevant marketing authorisation (MA) and confirming compliance with EU Guidelines for Good Manufacturing Practice & Annex 16: Certification by a Qualified Person & Batch Release.
-Fulfils the ethical, professional, & legal duties of the QP as outlined by Article 97 Veterinary Medicinal Directive 2019/6.
-Acquires and maintains detailed knowledge for all GMP manufacturing steps for which the QP undertakes responsibility as part of the batch certification process.
-Confirms the entire supply chain and robustness of associated pharmaceutical quality systems of the finished product lifecycle up to the stage of final batch certification, including the manufacturing and testing sites of all materials & packaging components for finished product & any other materials deemed critical through auditing & risk assessment of the manufacturing processes.
-Confirm all sites of manufacture, analysis & certification are compliant with the terms of the MA for the intended market.
-Responsible for confirming all audits of sites involved in the manufacture & the testing medicinal products.
-Confirm regulatory post-marketing commitments relating to manufacture or testing of the product have been addressed. 
-Ensure the impact of any change to product manufacturing or testing has been evaluated & any additional checks and tests are complete.
-Confirm the required Quality Agreements are in place across the Supply Chain for the product & effective prior to batch certification.
-Confirm the importation of active substances used in the manufacture of veterinary medicinal products complies with the requirements of Veterinary Medicinal Directive 2019/6.
-Support preparation for supervising competent authority HPRA & other regulatory audits.
-Review relevant modifications of the Quality Management System (QMS), including new & updated GMP procedures, forms, & documentation in accordance with HPRA standards & requirements.
-Cooperate in the exchange of information & assistance, as reasonably necessary to effectively respond to inquiries by regulatory authorities.
-Review responses to regulatory audit findings.
-Maintain a Continuous Professional Development plan, awareness of current Regulations & Guidelines, Legal Requirements & services of QP as stated under EU/HPRA Directive/Regulations or Guidelines.
-Adhoc duties as required.