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 contract 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 GMP
* Oversee all manufacturing, testing, and packaging activities to ensure operations are executed in alignment with cGMP, regulatory standards, and internal licensing requirements
* Manage the full lifecycle of batch documentation, ensuring accuracy, completeness, and sign-off by appropriately trained personnel
* Perform batch certification and release according to planned shipping timelines, ensuring all quality, regulatory, and documentation requirements are fulfilled
* Lead and guide investigation requirements for deviations, non-conformances, and quality-related incidents, ensuring timely and compliant resolution
* Confirm that manufacturing and analytical processes have undergone appropriate validation and that all required checks and controls have been executed
* Ensure any planned changes, deviations, or atypical results are escalated through established quality systems prior to release - including interactions with HPRA when required
* Initiate additional testing, inspections, or verifications when needed to support compliant batch disposition
* Drive continuous improvement across quality and operational processes, identifying opportunities to enhance efficiency and compliance
Manager 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 release
* Strong background within Quality Assurance, Quality Control, or Compliance in GMP-regulated environments
* Excellent understanding of EU GMP regulations, regulatory authority expectations, and quality system requirements
* Skilled in reviewing investigations, evaluating deviations and OOS events, and providing approval for batch-related quality decisions
* Experience with product recalls, change control oversight, and quality risk evaluation
* High attention to detail, strong analytical thinking, and proven capability to interpret complex data sets and documentation
* Familiarity with SAP or similar quality/manufacturing systems is advantageous
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us