Qualified Person (QP) (m/f/d) – Solid Oral Dosage

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

Qualified Person (QP) (m/f/d) – Solid Oral Dosage

for the site Killorglin, Ireland

Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you! Excellence beyond manufacturing - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Our site in Killorglin is a competence center for hard capsules.

Your key responsibilities

• Act as a registered Qualified Person on the site license, legally certifying and releasing solid oral dosage form bulk batches in accordance with EU GMP directives and HPRA regulations.


• Drive, maintain, and continuously improve site Quality Systems, including Change Control, Deviations, CAPA, Quality Risk Management (QRM), and Out of Specification (OOS) investigations.


• Ensure all manufacturing, packaging, and testing operations strictly align with the Marketing Authorization (MA) and Good Manufacturing Practice guidelines.


• Review and approve batch records and quality documentation to ensure regulatory compliance prior to release.


• Lead root-cause analysis and risk assessments for quality issues and batch-related investigations.


• Partner effectively with site operations, Quality Control, Supply Chain, and Regulatory Affairs to maintain high-quality standards and operational compliance.


• Participate actively in regulatory authority inspections and customer quality audits.

Your profile

• An accredited university degree in Pharmacy or a science degree in combination with a specialized, regulatory-approved postgraduate course


• 2+ years of industrial experience as a Qualified Person (QP) within a pharmaceutical manufacturing environment.


• Proven background in solid oral dosage manufacturing, batch release, and Quality Management Systems (QMS).


• Strong expertise in managing core Quality Systems processes (e.g., CAPA, Deviations, Change Control, Risk Assessment).


• Ability to work on-site in Killorglin to support site quality oversight and cross-functional teams.


• Leadership potential with genuine interest and ambition to progress into senior quality management and site leadership roles.


• High degree of accountability, ethical judgment, and decisive decision-making capabilities.


• Excellent written and verbal communication skills in English.

Your motivation

Are you looking for new challenges in a highly competitive environment? And you want to tackle them creativelyand on your own responsibility? Do you prefer a \"get-it-done\" culture and think in terms of solutions ratherthan problems? What are you waiting for? We would be happy to explain our corporate benefits in a personalconversation!

If you have any questions, I - Lukas Rödder / Human Resources - will be happy to help you: [phone]

Temmler Ireland Limited • Member of the Aenova Group • Killorglin • County Kerry • Ireland • V93 H972