Are you passionate about Quality Assurance in a fast-paced cGMP manufacturing environment? We are seeking a Quality Assurance Specialist to join a leading biopharmaceutical company at their state-of-the-art Carlow facility. This role is essential in ensuring compliance with regulatory standards while supporting manufacturing operations to deliver high-quality drug products.
About the Role:
This is a shift-based role within the Integrated Production Team (IPT), providing real-time quality oversight and ensuring compliance with cGMP and regulatory requirements. Key responsibilities include:
Key Responsibilities:
1. Batch Documentation & Compliance: Review and approve manufacturing batch documentation, including electronic batch records, SOPs, and cleaning validation reports.
2. Quality Oversight: Provide on-the-floor support, ensuring compliance in manufacturing operations, area clearances, and batch record reviews.
3. Deviation & Change Control Management: Collaborate with Quality Specialists and QA Leads to resolve queries and drive compliance initiatives.
4. GMP Training & Implementation: Support the training of teams on Quality Management Systems and regulatory compliance.
5. Continuous Improvement: Drive improvements through quality reporting measures, self-inspection programs, and compliance initiatives.
6. Cross-Functional Collaboration: Work with teams across Production, Microbiology, Utilities, and Maintenance to ensure quality and regulatory adherence.
7. Regulatory Audits & Inspections: Participate in audits, inspections, and plant-wide GMP initiatives.
What You Need to Succeed:
1. Degree qualified in Science, Technical, or a related discipline.
2. Experience in quality assurance within a pharmaceutical manufacturing environment.
3. Strong knowledge of US & European cGMP guidelines and regulatory requirements.
4. Experience in GMP audits, deviation management, and quality systems.
5. Ability to analyze trends, solve problems, and make risk-based quality decisions.
6. Excellent communication, people management, and project management skills.
7. A strong advocate for continuous improvement and innovation in quality compliance.
Why Join?
1. Opportunity to work in a cutting-edge biopharmaceutical facility.
2. Collaborative and innovative work environment.
3. Career progression opportunities in a globally recognized company.
4. Competitive salary and benefits package.
If you are a quality-driven professional looking to make an impact in pharmaceutical manufacturing, apply now or reach out for a confidential discussion.
The Next Step for You
Should this position be of interest, please apply through LinkedIn with an up-to-date CV to Jessica from Next Generation Recruitment or call us on the main line at 016629120.
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