Quality Assurance Specialist (Pharma Operations)

My client is seeking a Quality Assurance professional to lead QA activities at their R&D facility. This role is critical in maintaining a strong operational compliance focus aligned with cGMP principles and regulatory expectations. The position involves ensuring compliance with cGMPs, company policies, and applicable regulations. The successful candidate will bring expertise in FDA/EMEA-regulated environments and provide quality support, training, and guidance to the site.

Key Responsibilities

• Lead and participate in cross-functional teams to address compliance issues and meet project milestones.
• Investigate deviations, complaints, and changes, ensuring timely implementation of actions.
• Review and approve GMP documentation, including Change Controls, Deviations/CAPAs, and SOPs.
• Provide QA oversight for validation, technical transfers, regulatory approvals, and operations.
• Perform QA duties related to product disposition, including material release and eBR reviews.
• Evaluate new regulatory guidance and update Quality systems as needed.
• Develop and deliver training on QA SOPs and maintain QA policies and reports.
• Support continuous improvement initiatives and risk management activities.
• Conduct internal audits and foster a compliant and safety-focused culture.
• Escalate compliance risks to management promptly.

Qualifications and Experience

• Degree in Science, Quality, or Technical field.
• 8-10 years' experience in QA, QC, or Technical Operations within the biological or pharmaceutical industry.
• Expertise in QRM, investigations, and problem-solving as a Quality SME.
• Strong communication, attention to detail, and documentation skills.
• Familiarity with quality systems (e.g., Veeva, SAP, PAS-X).
• Knowledge of FDA, HPRA, EMEA, and other industrial regulations.
• Experience interacting with regulatory agencies during inspections.

The Next Step for you:

Should this position be of interest to you please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.

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