Senior Qualified Person – GMP Batch Release Expert

Pale Blue Dot®Recruitment Limited; Munster (IN); On-site; USD 80,000 - 125,000; Full time

Job summary

Pale Blue Dot®Recruitment Limited is seeking an experienced Qualified Person (QP) to join a senior Quality team in the Munster region. The successful candidate will certify finished product batches in line with GMP, regulatory requirements and site quality procedures.

Responsibilities include batch review, certification, and addressing deviations, CAPAs and change controls. The role supports regulatory inspections and QA systems development within a compliant manufacturing environment.

Qualifications

• Strong knowledge of GMP manufacturing and batch release.
• Experience in deviations, CAPA, change control and QA risks.
• Experience with HPRA or other authorities inspections.
• Experience operating in an Irish HPRA-regulated manufacturing environment.

Responsibilities

• Perform Qualified Person certification of finished product batches.
• Review batch manufacturing, packaging, testing and QA documentation prior to certification.
• Investigate deviations and OOS results and ensure appropriate CAPA.
• Provide QP input into deviations, CAPAs, change controls and investigations.
• Support regulatory inspections and GMP audits.
• Maintain documentation and records relating to batch certification and release.

Skills

GMP knowledge

Batch certification

Quality systems

Regulatory compliance

Cross-functional collaboration

Attention to detail

Strong communication

Education

QP status

Job description

Pale Blue Dot®Recruitment Limited is seeking an experienced Qualified Person (QP) to join a senior Quality team in the Munster region. The successful candidate will certify finished product batches in line with GMP, regulatory requirements and site quality procedures.

Responsibilities include batch review, certification, and addressing deviations, CAPAs and change controls. The role supports regulatory inspections and QA systems development within a compliant manufacturing environment.