Qualified Person: Solid Oral Dosage Release Lead

SwissCo Services AG / Aenova Group; Killorglin; On-site; EUR 70,000 - 100,000; Full time

Job summary

Temmler Ireland Limited, a member of the Aenova Group, seeks a Qualified Person (QP) for the Killorglin site in Ireland to certify solid oral dosage batches in line with EU GMP and HPRA requirements.

You will drive site quality systems, manage CAPA and risk assessments, review batch records, and collaborate with cross-functional teams to ensure regulatory compliance and product quality.

Qualifications

• University degree in Pharmacy or science with regulatory postgraduate qualification.
• 2+ years industrial experience as a Qualified Person (QP).
• Proven background in solid oral dosage manufacturing, batch release and QMS.
• Strong expertise in core Quality Systems processes (CAPA, Deviations, Change Control, Risk Assessment).
• Ability to work on-site in Killorglin, Ireland to support site quality oversight.

Responsibilities

• Act as the registered QP on the site license and release solid oral dosage form batches per EU GMP and HPRA rules.
• Drive and improve site Quality Systems, including CAPA, Deviations, and Change Control.
• Ensure manufacturing, packaging, and testing align with MA and GMP guidelines.
• Review batch records and quality documentation for regulatory release.
• Lead root-cause analysis and risk assessments for quality issues.
• Collaborate with Operations, QC, Supply Chain and Regulatory Affairs.
• Participate in regulatory inspections and customer quality audits.

Skills

Quality Systems

CAPA

Deviations

Change Control

Risk Assessment

On-site Collaboration

Regulatory Affairs

Education

Pharmacy degree or science degree with regulatory postgraduate course

Tools

QMS

Job description

Temmler Ireland Limited, a member of the Aenova Group, seeks a Qualified Person (QP) for the Killorglin site in Ireland to certify solid oral dosage batches in line with EU GMP and HPRA requirements.

You will drive site quality systems, manage CAPA and risk assessments, review batch records, and collaborate with cross-functional teams to ensure regulatory compliance and product quality.