Job Summary:
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The Quality Assurance Specialist will play a key role in supporting the qualification and validation of manufacturing operations, ensuring compliance with GMP and regulatory standards.
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About the Role:
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1. Serve as the site Quality Assurance point of contact, providing technical expertise, feedback, and guidance on quality and compliance matters.
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2. Manage assigned areas of the Quality Management System to ensure product manufacturing aligns with GMP and regulatory standards.
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3. Oversee QMS elements including deviations, change control, CAPA, internal/external audits, customer complaints, vendor management, and review/approval of manufacturing batch records.
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4. Generate, review, and approve SOPs and other documentation related to areas of responsibility.
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5. Conduct timely review and approval of site procedures and documentation to ensure alignment with GMP and regulatory requirements.
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6. Review and approve validation protocols, reports, and associated documentation to ensure compliance with EU regulatory standards and internal procedures.
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7. Maintain documentation schedules to support technology transfers and new product introduction timelines.
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8. Apply Quality Risk Management principles to all applicable activities.
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9. Act as QA lead on cross-functional project teams involving Operations, Quality Control, Engineering, and other departments.
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10. Actively contribute to site-wide continuous improvement initiatives.
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Requirements:
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* Strong understanding of GMP compliance and quality standards.
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* Excellent attention to detail with significant experience in document review.
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* Proficient in technical writing, including deviation reports and SOPs.
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* Strong time management and multitasking abilities.
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* Demonstrated ability to drive task completion, resolve issues, and maintain high-quality standards.
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* Excellent communication skills, both verbal and written.
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* Proficient in written and spoken English.
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* Strong team player with a collaborative mindset.
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* Third-level qualification in a relevant science or engineering discipline.
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* Minimum of 5 years' experience in a GMP-regulated Quality environment.
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* Experience in a Validation role with solid knowledge of the project lifecycle and current GMP regulations.
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