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QA Specialist
4 weeks ago
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A QA Specialist is required on an initial 12-Month basis by CareerWise Recruitment for our Cork-based multinational research-based pharmaceutical company.
This is a contract role within the QA Department, specifically in the QA packaging and labelling support team. The successful candidate will be responsible for QA approval and release of primary and secondary packaging components, review and approval of packaging and labelling documents, procedures, and GMP deviations. This position requires a strong knowledge of quality assurance systems, methods, and procedures. The candidate must exercise judgment within well-defined procedures, identify problems, and recommend appropriate actions proactively.
THE ROLE- Perform activities to ensure compliance with applicable cGxP regulatory requirements.
- Develop and implement Standard Operating Procedures (SOPs) and other controlled documents to meet quality objectives.
- Review and approve SOPs and other controlled documents.
- Perform QA review and release of packaging components and artwork.
- Identify deviations, evaluate impact, and determine appropriate corrective actions.
- Review and approve GMP deviation investigations and CAPAs.
- Review and approve master data and recipes for operations.
- Participate in data gathering to develop QA metrics.
- Contribute to compliance improvement, strategic, technical, and operational projects, and represent QA in cross-functional meetings.
- Assist with audits and walkthroughs to ensure GMP compliance.
- Collaborate with secondary packaging contractors on QA reviews of related documents.
- Maintain programs and processes to ensure product quality and GMP compliance.
Routine work is generally performed independently with minimal instruction, with general guidance on new assignments.
REQUIREMENTS- Experience in the pharmaceutical industry, preferably in a QA role.
- Knowledge of current Good Manufacturing Practices (cGMPs).
- Proficiency in QA principles, concepts, and standards.
- Understanding of FDA/EMEA standards and quality systems.
- Basic knowledge of OPEX Lean tools and root cause analysis.
- Strong audit, investigation, and report-writing skills.
- Excellent verbal, technical writing, and interpersonal skills.
- Proficiency in Microsoft Office.
- At least 4 years of experience in a GMP environment with a BS degree or 3 years with an MS degree.
- Positive, resilient, and team-oriented attitude.
- Ability to manage multiple stakeholders and adapt to challenging environments.
- Curiosity and learning agility.
- Organized with a systematic approach to prioritization.
