QA Specialist

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

QA Specialist

Our client, a pharmaceutical company in Co. Carlow are seeking a QA Specialist on an initial 11 month contract. This is a hybrid position with no shift requirements.

Responsibilities:

• Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business
• activities.
• Attend and successfully complete applicable cGMP training.
• Responds to Operational and business area's, drives compliance with cGMP and corporate regulations.
• Drives cGMP/GDP compliance in the performance of day-to-day business activities.
• Escalate any potential violation of cGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of MMD human health products and aids resolution
• Liaise with the Quality/ Business Area Specialists/QP/QA Lead to resolve quality related queries where required
• Provides expertise C quality support for the introduction of new products onto site in relation to product release where required
• Ensure and promote that adequate processes and procedures are in place and followed for all Quality activities.
• Report on and assist with monitoring the Quality Management Systems. Generate reports for performance metrics and significant quality events C issues.
• Review and approval of all manufacturing batch/ material documentation
• including electronic batch records, real time reports, master data using the site systems where required.
• Identify, influence and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.

Requirements:

• Bachelor's degree in Science, Engineering, Quality, Biotechnology, Pharmaceutical Sciences, Chemistry, Microbiology, or a related technical discipline.
• Typically 3 to 5 years' experience in a regulated pharmaceutical, biotechnology, medical device, or healthcare manufacturing environment.
• Demonstrated experience working within Quality Systems and Compliance
• functions, including management of quality records, deviations, CAPAs, change controls, investigations, Complaints and document management systems.
• Knowledge of current GMP requirements and quality system standards applicable to pharmaceutical manufacturing.
• Experience collaborating with cross-functional teams including Manufacturing, Engineering, Laboratory, Supply Chain, and Technical Operations.

Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-group.com.

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone David O'Connell at 086 1263871 or send your CV to [e-mail]