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
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