Qualified Person – GMP/QA Lead (Hybrid)

PCI TRGR Penn Pharmaceutical Services Ltd; Killiney; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

PCI Pharma Services is seeking a Qualified Person to join our clinical team in Ireland. This hybrid/remote role requires certification as a QP or eligibility, with extensive quality management experience in the pharma industry.

You will certify IMPs, support GMP/GCP compliance, and lead quality systems while coordinating with cross-functional teams to ensure high standards across manufacturing and release processes. Equal opportunity employer.

Qualifications

• Bachelor’s degree in science, engineering, technology or related discipline.
• Qualified Person status or eligibility for QP status.
• 3–5 years’ experience in a quality management role in pharma.
• Sound knowledge of EU GMP requirements.
• Excellent organizational and leadership abilities.
• Sterile experience is desirable but not essential.

Responsibilities

• Certify IMPs in accordance with Protocol, IMPD and PSF.
• Provide QA guidance to ensure GMP/GCP compliance.
• Review batch documentation and release reports.
• Support CAPA, deviations, change control and investigations.
• Audit support for Health Authority inspections and supplier audits.
• Mentor QA specialists and provide supervisory support as needed.

Skills

Quality management

Leadership

Interpersonal communications

Time management

Education

Bachelor's degree in science/engineering/related discipline

QP status or eligibility

Job description

PCI Pharma Services is seeking a Qualified Person to join our clinical team in Ireland. This hybrid/remote role requires certification as a QP or eligibility, with extensive quality management experience in the pharma industry.

You will certify IMPs, support GMP/GCP compliance, and lead quality systems while coordinating with cross-functional teams to ensure high standards across manufacturing and release processes. Equal opportunity employer.