Manager Qualified Person (QP)

Mantell Associates is partnered with a leading Pharmaceutical organisation in Ireland, who is seeking an experienced Manager Qualified Person (QP) to take responsibility for the certification and release of commercial product batches. This is a critical on-site permanent role requiring a fully qualified QP with proven experience releasing products within Ireland and/or the EU.Manager Qualified Person (QP) - Responsibilities:Act as the site’s QP, ensuring that all finished products meet the conditions of the Marketing Authorisation and have been manufactured in full compliance with EU GMPOversee all manufacturing, testing, and packaging activities to ensure operations are executed in alignment with cGMP, regulatory standards, and internal licensing requirementsManage the full lifecycle of batch documentation, ensuring accuracy, completeness, and sign-off by appropriately trained personnelPerform batch certification and release according to planned shipping timelines, ensuring all quality, regulatory, and documentation requirements are fulfilledLead and guide investigation requirements for deviations, non-conformances, and quality-related incidents, ensuring timely and compliant resolutionConfirm that manufacturing and analytical processes have undergone appropriate validation and that all required checks and controls have been executedEnsure any planned changes, deviations, or atypical results are escalated through established quality systems prior to release - including interactions with HPRA when requiredInitiate additional testing, inspections, or verifications when needed to support compliant batch dispositionDrive continuous improvement across quality and operational processes, identifying opportunities to enhance efficiency and complianceManager Qualified Person (QP) - Requirements:Must be a Qualified Person (QP) as defined under EU Directive requirements, such as Registered Pharmacist / Graduate of a recognised Diploma in Pharmaceutical Manufacturing Technology / Equivalent qualification accepted for QP status within the EU.Demonstrated experience acting as a QP within the pharmaceutical industry in Ireland/EU, with accountability for batch certification and releaseStrong background within Quality Assurance, Quality Control, or Compliance in GMP-regulated environmentsExcellent understanding of EU GMP regulations, regulatory authority expectations, and quality system requirementsSkilled in reviewing investigations, evaluating deviations and OOS events, and providing approval for batch-related quality decisionsExperience with product recalls, change control oversight, and quality risk evaluationHigh attention to detail, strong analytical thinking, and proven capability to interpret complex data sets and documentationFamiliarity with SAP or similar quality/manufacturing systems is advantageousMantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.