Quality Assurance Specialist

Fastnet; Cork; On-site; EUR 45,000 - 65,000; Full time

Job summary

A leading company is seeking a Contract QA Specialist in Cork to ensure quality oversight across manufacturing operations. This role demands a Bachelor's degree in related fields and at least 2 years of experience in a GMP environment, ensuring compliance with stringent regulatory standards.

Qualifications

• 2+ years’ experience in Quality Assurance within a GMP-regulated environment.
• Strong knowledge of compliance and quality oversight.
• Promote a culture of continuous improvement in quality systems.

Responsibilities

• Review and approve batch documentation, including BMRs and release documents.
• Manage deviations, CAPAs, and change controls as per procedures.
• Provide QA oversight for validation and qualification activities.

Skills

Attention to detail

Communication

Organisational skills

Knowledge of deviation management

Quality systems

Education

Bachelor’s degree in Science, Pharmacy, Engineering

Tools

TrackWise

Veeva

SAP

Job description

Job Title: Contract QA Specialist

Role Summary:

We are seeking experienced QA Specialists to support GMP-compliant operations at manufacturing sites in Cork. These contract roles involve providing quality oversight across manufacturing, validation, and supply chain activities, ensuring compliance with regulatory and internal standards.

Key Responsibilities:

• Review and approve batch documentation, including Batch Manufacturing Records (BMRs) and associated release documentation
• Manage and support deviations, CAPAs, and change controls in accordance with site procedures
• Provide QA oversight for validation and qualification activities
• Support audit readiness and participate in internal and external inspections
• Collaborate cross-functionally with production, engineering, QC, and regulatory teams
• Ensure all activities are aligned with GMP, EHS, and data integrity standards
• Promote a culture of continuous improvement in compliance and quality systems

Essential Requirements:

• Bachelor’s degree in Science, Pharmacy, Engineering, or related discipline
• 2+ years’ experience in Quality Assurance within a GMP-regulated environment
• Strong knowledge of deviation management, batch review, and quality systems
• Excellent attention to detail, communication, and organisational skills

Desirable:

• Experience with manufacturing QA, validation QA, or QA support of tech transfers
• Familiarity with systems such as TrackWise, Veeva, or SAP
• Previous involvement in regulatory audits (HPRA, FDA, EMA)
• Understanding of data integrity principles and electronic systems compliance