Senior Qualified Person (QP) - GMP Batch Release Expert

Pale Blue Dot Recruitment; Munster; On-site; EUR 90,000 - 130,000; Full time

Job summary

Pale Blue Dot Recruitment is assisting an established pharmaceutical manufacturer in the Munster region to recruit a Senior Qualified Person (QP) to join the Quality team.

The successful candidate will certify finished product batches, review documentation and ensure compliance with GMP, regulatory requirements and Marketing Authorisations. This is a senior role with strong QA focus and cross-functional collaboration.

Qualifications

• Qualified Person status with the appropriate qualifications for Ireland.
• Experience carrying out QP responsibilities in a GMP-regulated pharmaceutical environment.
• Strong working knowledge of EU GMP requirements and pharmaceutical quality systems.
• Experience in batch review, certification and release.
• Knowledge of deviations, investigations, CAPA, change control and quality risk management.
• Experience supporting regulatory inspections and GMP audits.
• Strong technical judgement and the ability to make independent quality decisions.
• Excellent attention to detail and documentation standards.
• Strong communication and cross-functional collaboration skills.
• Ability to operate effectively within a regulated manufacturing environment.
• Experience within an HPRA-regulated manufacturing environment in Ireland.
• Experience supporting HPRA inspections.
• Broad experience across pharmaceutical manufacturing, QA and batch certification.

Responsibilities

• Perform Qualified Person certification of finished product batches in accordance with regulatory and GMP requirements.
• Review batch manufacturing, packaging, testing and related quality documentation prior to certification.
• Investigate and resolve deviations, OOS results and other quality events impacting batch certification.
• Provide QP input into deviations, CAPAs, change controls and investigations.
• Support the Pharmaceutical Quality System and its ongoing development.
• Provide quality guidance for manufacturing, testing, packaging and release activities.
• Assist regulatory inspections and GMP audits as required.
• Collaborate with Quality Assurance, Quality Control, Manufacturing and other functions to maintain GMP compliance.
• Support continuous improvement of quality systems, procedures and compliance processes.
• Maintain documentation and records relating to batch certification and release.
• Stay current with GMP requirements, regulatory guidance and legislation.

Skills

GMP knowledge

Quality Assurance

Regulatory compliance

Documentation

Cross-functional collaboration

Audits/inspections

Batch release

Job description

Pale Blue Dot Recruitment is assisting an established pharmaceutical manufacturer in the Munster region to recruit a Senior Qualified Person (QP) to join the Quality team.

The successful candidate will certify finished product batches, review documentation and ensure compliance with GMP, regulatory requirements and Marketing Authorisations. This is a senior role with strong QA focus and cross-functional collaboration.