Manager Qualified Person (QP)

Mantell Associates; Leinster; On-site; EUR 70,000 - 90,000; Full time

Job summary

A leading recruitment firm in pharmaceuticals is seeking an experienced Manager Qualified Person (QP) to oversee the certification and release of commercial product batches in Ireland. The ideal candidate will possess a QP qualification, strong background in Quality Assurance, and experience in GMP-regulated environments. This permanent on-site role promises significant responsibility in ensuring GMP compliance across operations.

Qualifications

• Must be a Qualified Person (QP) as per EU Directive requirements.
• Demonstrated experience acting as a QP within the pharmaceutical industry.
• Strong background in Quality Assurance in GMP-regulated environments.

Responsibilities

• Act as the site’s QP ensuring compliance with EU GMP.
• Oversee production operations to meet quality and regulatory standards.
• Manage batch documentation lifecycle and perform batch certification.

Skills

Quality Assurance

Regulatory Compliance

Analytical Thinking

Attention to Detail

Education

Registered Pharmacist

Diploma in Pharmaceutical Manufacturing Technology

Tools

SAP

Job description

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 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 at [phone].