Pharma QA Specialist: Process & Compliance Leader

PE Global (UK); Carlow; Hybrid; EUR 42,000 - 52,000; Part time

Job summary

PE Global is seeking a QA Specialist for a 11-month hybrid contract in Carlow. The role focuses on QA oversight across analytical, warehouse and facilities management, with exposure to deviations, CAPAs and change controls.

You will review documentation for new product introductions and participate in supplier qualification and performance reviews. The ideal candidate has 3–5 years in a pharmaceutical quality role, knowledge of cGMP/GDP, and strong documentation skills.

Qualifications

• 3–5 years of experience in a quality role, ideally in pharmaceutical manufacturing.
• Knowledge of Irish, European, and International codes, standards and practices.
• Familiarity with cGMP and GDP is preferred.
• Strong report writing and policy documentation skills.
• Experience with equipment and process validation.

Responsibilities

• Provide QA oversight to support analytical, warehouse and facilities management, incl deviations, root cause analysis, CAPAs and change controls.
• Act as a functional expert in the cross-functional team for introducing products and materials at Carlow.
• Review documentation for new product/material introductions (Material Packs, QC specs, BOMs, supplier qualification).
• Develop and monitor supplier performance metrics and participate in supplier reviews.
• Maintain the supplier management list in the QC system and ensure correct setup.
• Support deviation closure and corrective/preventive actions.
• Author and approve protocols/reports for technology transfer, method qualification/validation.
• Conduct quality reviews of engineering/validation/automation/utilities commissioning.
• Serve as site quality contact and coordinate quality working group meetings.
• Ensure compliance with divisional policies and regulatory requirements; drive site improvements.

Skills

QA Oversight

Documentation review

CAPA

Root cause analysis

Change controls

Supplier management

Quality audits

Regulatory knowledge

Analytical skills

MS Office

Education

Bachelor's degree in science

Tools

MS Office

Job description

PE Global is seeking a QA Specialist for a 11-month hybrid contract in Carlow. The role focuses on QA oversight across analytical, warehouse and facilities management, with exposure to deviations, CAPAs and change controls.

You will review documentation for new product introductions and participate in supplier qualification and performance reviews. The ideal candidate has 3–5 years in a pharmaceutical quality role, knowledge of cGMP/GDP, and strong documentation skills.