Senior Qualified Person (QP) – Solid Oral Dosage

Aenova Group; Killorglin; Remote; EUR 90,000 - 120,000; Full time

Job summary

Temmler Ireland Limited, a member of the Aenova Group, seeks a Qualified Person (QP) for Killorglin, Ireland. The role releases solid oral dosage batches and drives site quality systems in a GMP environment.

You will ensure compliance with MA and EU/HPRA regulations, lead investigations, and partner with cross-functional teams to maintain high quality standards at the Killorglin site.

Qualifications

• Pharmacy degree or science degree with regulatory postgraduate coursework.
• At least 2 years of industrial QP experience in pharma manufacturing.
• Proven background in solid oral dosage, batch release and QMS processes.

Responsibilities

• Act as a registered Qualified Person on the site license and certify solid oral dosage bulk batches.
• Drive and improve site Quality Systems including CAPA, Deviations, Change Control and QRM.
• Review batch records for regulatory compliance prior to release.
• Lead root-cause analysis and risk assessments for quality issues and investigations.
• Collaborate with operations, QC, Supply Chain and Regulatory Affairs to maintain compliance.
• Support regulatory inspections and customer quality audits.

Skills

QP experience

QMS expertise

Solid oral dosage

Batch release

Education

Accredited Pharmacy degree

Science degree + regulatory postgraduate

Job description

Temmler Ireland Limited, a member of the Aenova Group, seeks a Qualified Person (QP) for Killorglin, Ireland. The role releases solid oral dosage batches and drives site quality systems in a GMP environment.

You will ensure compliance with MA and EU/HPRA regulations, lead investigations, and partner with cross-functional teams to maintain high quality standards at the Killorglin site.