
QA Specialist
2 weeks ago
This organisation is a manufacturer, marketer, and distributor of veterinary pharmaceuticals and animal health products.
ResponsibilitiesQuality System Management
- Implement, maintain, and improve the Quality Management System (QMS) in accordance with GMP (Good Manufacturing Practices), VICH, FDA (21 CFR Part 210/211/226 for veterinary drugs), EMA, or WHO standards.
- Ensure compliance with Veterinary Medicinal Product Regulations and Good Distribution Practices (GDP).
Document Control
- Manage SOPs, batch records, specifications, and protocols.
- Ensure controlled distribution, versioning, review, and archiving of all QA documentation.
Batch Record Review and Product Release
- Review batch manufacturing and packaging records for accuracy and compliance.
- Approve and release raw materials, intermediates, and final products for distribution.
Deviation, CAPA, and non-conformance Management
- Initiate and track CAPAs (Corrective and Preventive Actions) and ensure timely closure.
- Bachelor's degree in a science related field.
- 2-3 years experience in a GMP environment.
- Knowledge of Good Manufacturing Practices (GMP) - especially veterinary GMPs.
- Knowledge of FDA (CVM), EMA, VICH, and USDA regulatory requirements.
- Knowledge of GLP, GDP, and ISO standards (e.g., ISO 9001).
- Knowledge of Quality Management Systems (QMS).
To discover more about this opportunity please apply online or contact Darragh on +353 879345234 for a confidential discussion.
Seniority level- Entry level
- Contract
- Quality Assurance
- Pharmaceutical Manufacturing
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