Hybrid QA Specialist: cGMP & Batch Release

Berkley Group; Carlow; Hybrid; EUR 45,000 - 65,000; Full time

Job summary

Berkley Group Ireland is seeking a QA Specialist for a pharmaceutical client in Co. Carlow. This is an 11-month hybrid role with no shift requirements, offering a pathway to ongoing opportunities.

You will support data integrity under ALCOA, drive cGMP compliance, review manufacturing batch records, and contribute to quality events and QMS reporting. Collaboration with cross‑functional teams is essential in this role.

Qualifications

• Bachelor's degree in a related technical discipline.
• Typically 3–5 years' experience in a regulated pharmaceutical or manufacturing environment.
• Demonstrated experience with quality systems including deviations, CAPAs, change controls, investigations, and document management.
• Knowledge of current GMP requirements and quality system standards for pharmaceutical manufacturing.
• Experience collaborating with cross-functional teams including Manufacturing, Engineering, Laboratory, and Supply Chain.

Responsibilities

• Ensure ALCOA data integrity for records and data.
• Complete applicable cGMP training.
• Drive compliance with cGMP and corporate regulations.
• Support quality activities for product release and batch documentation reviews.
• Review and approval of manufacturing batch/material documentation and electronic batch records.
• Monitor and report on Quality Management Systems and significant quality events.

Skills

ALCOA data integrity principles

cGMP training

Quality Systems

Cross-functional collaboration

Documentation management

Education

Bachelor's degree in Science or related technical discipline

Tools

QMS software

Document management system

Job description

Berkley Group Ireland is seeking a QA Specialist for a pharmaceutical client in Co. Carlow. This is an 11-month hybrid role with no shift requirements, offering a pathway to ongoing opportunities.

You will support data integrity under ALCOA, drive cGMP compliance, review manufacturing batch records, and contribute to quality events and QMS reporting. Collaboration with cross‑functional teams is essential in this role.