Quality Engineer — GMP & CAPA Specialist (12mo Contract)

PE Global; Sligo; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

PE Global is recruiting a Quality Engineer for a leading pharmaceutical company in Sligo on a 12‑month contract. You will ensure product compliance with specifications and GMP, working as part of the Quality Team to meet quality goals.

Responsibilities include coordinating the Quality System, handling CAPA, investigations, batch release, supplier quality, and regulatory compliance. The role requires a degree in engineering/science and 2+ years in a regulated quality environment.

Qualifications

• Degree in engineering, science, or quality discipline.
• Green Belt and statistical knowledge desirable.
• At least 2 years in day‑to‑day quality system operations in a regulated manufacturing environment.
• Experience in injection moulding or tooling environment is desirable.

Responsabilités

• Coordinate elements of the Quality System to ensure GMP compliance.
• Audit the quality system with relevant personnel.
• Assist in investigation of customer complaints and CAPA actions.
• Manage day‑to‑day CAPA initiation, investigation, correction and follow‑up.
• Measure performance of the Quality System and provide monthly metrics.
• Provide training to plant personnel on quality requirements.
• Keep management informed of system failures for corrective/preventive actions.
• Verify effectiveness of CAPA and non‑conformances.
• Ensure compliance with regulatory requirements and assist validation activities.
• Ensure QMS documentation is thorough and compliant.
• Review batch records and perform lot release for shipment.
• Inspect incoming product and manage supplier Quality relationships.
• Participate in continuous improvement programs across quality, safety, environment and production.
• Review batch records and complete disposition where required.
• Participate in risk management activities.

Connaissances

Statistical knowledge

Quality system awareness

Regulatory compliance

Formation

Engineering/Science degree

Quality assurance in regulated environment

CFR 21 Part 820 knowledge

ISO13485 knowledge

Description du poste

PE Global is recruiting a Quality Engineer for a leading pharmaceutical company in Sligo on a 12‑month contract. You will ensure product compliance with specifications and GMP, working as part of the Quality Team to meet quality goals.

Responsibilities include coordinating the Quality System, handling CAPA, investigations, batch release, supplier quality, and regulatory compliance. The role requires a degree in engineering/science and 2+ years in a regulated quality environment.