Qualified Person

4 weeks ago

Sligo, Sligo, Ireland Team Horizon Full time

Team Horizon is seeking a Qualified Person for our Clients manufacturing facility in the Northwest. Reporting to the Quality Manager this role will be responsible for robust QA oversight of vaccine commercial products. Specifically, this position will be responsible for the Quality Oversight and batch certification of finished product.Why you should apply: * This is a unique opportunity to be involved in the expansion phase of a world-class biopharma plant. * Join an expanding team of energetic solutions-oriented people who are dedicated to providing solutions for a healthier worldWhat you will be doing: * Ensure each commercial batch has been manufactured, tested and 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 and Annex 16: Certification by a Qualified Person and Batch Release. * Fulfils the ethical, professional, and legal duties of the Qualified Person as outlined by Article 97 Veterinary Medicinal Directive 2019/6. * Acquire and maintain detailed knowledge for all GMP manufacturing steps for which the QP undertakes responsibility as part of the batch certification process. * Confirm 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 and packaging components for finished product and any other materials deemed critical through auditing and risk assessment of the manufacturing processes. * Confirm all sites of manufacture, analysis and certification are compliant with the terms of the MA for the intended market, with all manufacturing activities and testing activities consistent with those described in the MA. * Confirm audits of sites involved in the manufacture and the testing of the medicinal products including the manufacture of the active substance have been completed and that the audit reports are available prior to batch certification. * 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 and any additional checks and tests are complete. * Confirm the required Quality Agreements are in place across the Supply Chain for the product and 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 and other regulatory audits. * Review relevant modifications of the Quality Management System (QMS), including new and updated GMP procedures, forms, and documentation in accordance with HPRA standards and requirements. * Cooperate in the exchange of information and assistance, as reasonably necessary to effectively respond to inquiries by regulatory authorities e.g. HPRA and DAFM & Review responses to regulatory audit findings. * Maintain a Continuous Professional Development plan, maintain awareness of current Regulations & Guidelines, Legal Requirements and carry out the services of Qualified Person as stated under EU/HPRA Directive/Regulations or Guidelines. Maintain knowledge and training related to GMP up to date. * Carry out additional duties associated with the role as delegated.What you need to apply: * Academic and practical experience in compliance with Article 97 Veterinary Medicinal Directive 2019/6, and fulfil the conditions required to act in the capacity of Qualified Person. * Experience as a named QP for a licensed facility preferable. * Sterile manufacturing and/or biotech experience preferrable. * Application of cGMP to manufacturing and testing. * Excellent technical and compliance-based writing skills. * Managerial or Supervisory experience preferable. * Experience in supporting both regulatory agency inspections and internal GMP audits. * Fluent in written and spoken English. * Proficient in use of MS Excel, Word and PowerPoint. MS Project an advantage

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