Qualified Person – IMP Release & GMP Expert

PCI Pharma Services; Leinster; On-site; EUR 70,000 - 95,000; Full time

Job summary

PCI Pharma Services in Stamullen, Co. Meath, Ireland, is seeking a Qualified Person to certify investigational medicinal products and ensure compliance with EU GMP and project specifications.

The role involves collaboration with QA, manufacturing, and regulatory teams to uphold product quality and patient safety. The successful candidate will have a scientific degree, QP status or eligibility, and 3-5 years of quality management experience in pharma, with sterile experience and strong leadership

Qualifications

• Bachelor's degree in science, engineering, technology or a related discipline.
• Qualified Person status or eligibility for QP status, with clinical experience desirable.
• 3-5 years' experience in a quality management role in the pharma industry.
• Steriles experience desirable; extensive knowledge of EU GMP.

Responsibilities

• Review and certify clinical batches and ensure cGMP/GCP compliance.
• Lead CAPA and change control processes and cross-functional collaboration.
• Support regulatory inspections and supplier quality management.
• Maintain and improve quality systems and process excellence.
• Provide training and mentorship to QA staff.

Skills

Bachelor's degree

QP status

Quality management

Sterile experience

EU GMP

Quality systems

Leadership

Time management

People management

Management experience

Adaptability

Education

Bachelor's degree in science/engineering/technology or related discipline

Job description

PCI Pharma Services in Stamullen, Co. Meath, Ireland, is seeking a Qualified Person to certify investigational medicinal products and ensure compliance with EU GMP and project specifications.

The role involves collaboration with QA, manufacturing, and regulatory teams to uphold product quality and patient safety. The successful candidate will have a scientific degree, QP status or eligibility, and 3-5 years of quality management experience in pharma, with sterile experience and strong leadership