Website Asset Recruitment

Asset Recruitment

Ref: 01208

QA Specialist – Hybrid / 6 month contract

This position supports Quality Assurance activities at a leading Research & Development facility in Dunboyne. As a Quality Assurance Specialist, you will be a crucial part of the quality team, ensuring the facility maintains a strong focus on operational compliance, aligned with the principles and expectations of current Good Manufacturing Practices (cGMP) regulations.

Responsibilities:

Lead and actively participate in cross-functional teams to address compliance issues and achieve project milestones.

Conduct investigations and risk assessments for deviations, complaints, and changes, ensuring timely implementation of appropriate actions.

Review and approve Change Controls, Deviations/CAPAs, SOPs, and related documents for compliance with GMP and site requirements.

Provide Quality Assurance oversight for Microbial and Analytical Method Validation, Analytical/Microbial Technical Transfers, regulatory approvals, and both clinical and commercial operations.

Support product disposition by performing detailed reviews of electronic Batch Records (eBR) prior to Qualified Person (QP) release and material release.

Promote continuous improvement by identifying and implementing efficiencies and quality enhancements.

Participate in and support risk management activities in accordance with relevant guidelines and industry best practices.

Collaborate with management and colleagues to foster a safe and compliant workplace culture.

Ensure timely escalation of compliance risks to management.

Qualifications:

Bachelor’s degree in Science, Quality, or a related technical field.

5-10 years of experience in QA, QC, or Technical Operations, ideally within the biological or pharmaceutical industry.

Proven project management skills with a strong understanding of operations.

Expertise in Quality Risk Management (QRM), investigations, and problem-solving as a Quality Subject Matter Expert (SME).

Excellent written and verbal communication skills.

Logical thinker and can perform well under pressure.

Capable of working both independently and collaboratively in a constructive manner.

High attention to detail and precision in preparing and reviewing GMP documentation.

Proficient in quality management systems such as Veeva, SAP, and PAS-X.

Knowledgeable about industrial regulations including FDA, HPRA, EMEA, and other regulatory bodies relevant to biologics and pharmaceuticals.

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