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Job Description
Experienced QA Specialist sought for a rapidly growing biopharmaceutical manufacturer in Carlow, responsible for ensuring manufacturing compliance with cGMP and regulatory requirements.
We are currently looking for a highly skilled QA Specialist to join our team in Carlow. As a key member of our quality team, you will be responsible for ensuring the manufacturing of drug products is compliant with cGMP and associated regulatory requirements.
Key Responsibilities:
- Review of batch documentation, SOPs, cleaning verification and validation data
- Support development and implementation of improved quality documentation and procedures
- Provide real-time shop floor support for daily manufacturing operations
- Quality input into shop floor decision making
- Provide training in all aspects of QMS and GMP
- Aid the effective implementation of the Quality Management System and facilitate continuous improvement
- Actively participate in Plant/Quality committees and work with other site functional groups
- Contribute to continuous improvement initiatives and ensure the department maintains inspection readiness
Requirements:
- Third Level Degree qualified in a Science/Technical or related discipline
- Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment
- Knowledge of US and European cGMP guidelines, and other international regulatory requirements
- GMP Audit experience in the pharmaceutical industry