Qualified Person - QP

Berkley Group; Limerick; On-site; EUR 110,000 - 140,000; Full time

Job summary

Berkley Group in Limerick, Ireland seeks a senior Qualified Person (QP) to oversee biotech operations. You will certify and release biotech drug substances and products, ensure documentation quality, and provide independent QA leadership in a highly automated manufacturing setting.

The role requires 8+ years in QA within biotech/pharma, a degree in a relevant field (MSc/PhD preferred), and eligibility to act as a QP under Irish/EU regulations.

Qualifications

• Degree in Biology, Chemistry, Pharmacy or a related scientific discipline (MSc/PhD preferred).
• Approximately 8+ years of QA experience in biotechnology or pharmaceutical manufacturing.
• Experience acting as a named QP for commercial or investigation medicinal products.
• Experience with biologics or biotechnology drug substance and/or drug product manufacturing.
• Experience working in a modern, highly automated manufacturing environment.
• Experience with technology transfer, process validation, continued process verification, and manufacturing start-up.
• Eligible and approved to act as a Qualified Person and named on the applicable manufacturing authorization.
• Strong knowledge of EU GMP and pharmaceutical regulatory requirements.
• Experience with batch certification and disposition, data integrity, and risk management.

Responsibilities

• Act as an approved Qualified Person in accordance with Irish and EU requirements.
• Make the final quality decision for certification and release of biotech drug substance and product batches.
• Review batch documentation, analytical results, deviations, investigations and quality records before certification.
• Issue QP declarations and other required QP certifications.
• Provide QA leadership and technical expertise for biotechnology operations.
• Maintain a visible GMP presence within manufacturing and supporting areas.
• Promote a proactive quality culture focused on patient safety and product quality.
• Guide and train personnel on GMP expectations and regulatory requirements.
• Monitor GMP compliance and site quality systems implementation.
• Oversee site self-inspection and internal audits across manufacturing, labs and facilities.
• Identify compliance risks and drive remediation and escalation.

Skills

Quality Assurance experience

GMP knowledge

Regulatory compliance

Data integrity understanding

Cross-functional collaboration

Education

Biology/Chemistry/Pharmacy degree

MSc or PhD preferred

Job description

Global Pharmaceutical company based in Limerick, Ireland - looking for experienced Qualified person - QP.The Qualified Person (QP) - Biotechnology Operations is a senior Quality Assurance role responsible for ensuring that biotechnology products manufactured at company site are produced, tested, documented, and released in compliance with applicable EU GMP requirements, manufacturing and marketing authorizations, and company quality standards. The QP provides independent quality oversight and makes the final decision on the certification and release of applicable biotech drug substances and drug product batches. The role combines regulatory accountability, technical quality leadership, GMP oversight, batch disposition, and cross-functional influence across Manufacturing, Quality Control, Engineering, MSAT, Regulatory, Supply Chain, and other site functions.

The role:

• Act as an approved Qualified Person in accordance with applicable Irish and EU requirements.
• Make the final quality decision for the certification and release of applicable biotech drug substance and drug product batches.
• Ensure all required batch documentation, analytical results, deviations, investigations, and quality records have been appropriately reviewed before certification.
• Issue QP declarations and other required QP certifications.
• Provide Quality leadership, direction, governance, and technical expertise for assigned biotechnology operations.
• Maintain a strong and visible GMP presence within manufacturing and supporting operational areas.
• Promote a proactive quality culture based on patient safety, product quality, compliance, and continuous improvement.
• Provide guidance and training to personnel on GMP expectations, regulatory requirements, and quality principles.
• Monitor GMP compliance and the effective implementation of site quality systems.
• Participate in and oversee site self-inspection and internal audit programmes.Audit manufacturing, laboratory, engineering, facilities, and service areas as required.
• Identify compliance risks and ensure appropriate remediation and escalation.

Have You:

• Degree in Biology, Chemistry, Pharmacy, or another relevant scientific discipline; MSc, or PhD.
• Approximately 8+ years of relevant Quality Assurance experience in biotechnology or pharmaceutical manufacturing.
• Previous experience acting as a named QP for commercial and/or investigations medicinal products.
• Experience with biologics or biotechnology drug substance and/or drug product manufacturing.
• Experience working in a modern, highly automated manufacturing environment.
• Experience with technology transfer, process validation, continued process verification, and manufacturing start-up.
• Eligible and approved by the relevant Member State competent authority to act as a Qualified Person and to be named on the applicable manufacturing authorization.
• Significant experience in Quality Assurance within a pharmaceutical or biotechnology manufacturing environment.
• Strong knowledge of EU GMP and pharmaceutical regulatory requirements.
• Experience with batch certification and disposition.
• Strong knowledge of GMP quality systems and pharmaceutical manufacturing processes.
• Demonstrated understanding of regulatory expectations relating to data integrity, quality risk management, validation, and product quality.

The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.