Impactful QP: Release, Compliance & Quality Lead

Morgan McKinley; Munster; On-site; EUR 70,000 - 110,000; Full time

Job summary

Morgan McKinley is partnering with a well-established SME pharmaceutical business in Ireland to appoint a Qualified Person (QP) to join its site Quality team. The role involves ownership of batch certification and release, contributing to continuous improvement, and driving a culture of quality across the business.

You will ensure compliant batch certification, maintain robust QMS, and work with cross-functional teams to uphold regulatory standards.

Qualifications

• Accredited degree in Pharmacy or relevant science with regulatory postgraduate qualification.
• At least 2 years of industrial experience as a Qualified Person in a pharmaceutical manufacturing environment.
• Experience with batch certification, release and Quality Management Systems.
• Knowledge of CAPA, Deviations, Change Control, Risk Assessment and OOS investigations.
• Willingness to work on-site to provide effective quality oversight and engage cross-functionally.
• Strong written and verbal English communication; able to build relationships across the organization.

Responsibilities

• Act as a registered Qualified Person on the site licence, certifying and releasing batches per EU GMP and regulatory standards.
• Drive and improve Quality Systems including Change Control, Deviations, CAPA, QRM and OOS investigations.
• Ensure manufacturing, packaging and testing align with Marketing Authorisations and EU GMP requirements.
• Review and approve batch records and quality documentation prior to release.
• Lead root-cause analyses and risk assessments related to quality issues and batch discrepancies.
• Collaborate with Manufacturing, Quality Control, Supply Chain and Regulatory Affairs to uphold quality and compliance.
• Support regulatory inspections and customer quality audits to demonstrate compliance and a strong quality culture.
• Partner with the Head of Quality on day-to-day quality matters and continuous improvement.

Skills

Quality oversight

Regulatory compliance

Root cause analysis

Cross-functional collaboration

Attention to detail

English communication

Education

University degree in Pharmacy or relevant science

Postgraduate regulatory qualification

Job description

Morgan McKinley is partnering with a well-established SME pharmaceutical business in Ireland to appoint a Qualified Person (QP) to join its site Quality team. The role involves ownership of batch certification and release, contributing to continuous improvement, and driving a culture of quality across the business.

You will ensure compliant batch certification, maintain robust QMS, and work with cross-functional teams to uphold regulatory standards.