Our organization is seeking a highly skilled Quality Assurance Professional to join our team on a permanent, full-time basis. This role offers the opportunity to work in a collaborative and dynamic environment with a leading manufacturer.
The successful candidate will play a key role in quality assurance activities, supporting the qualification and validation of manufacturing operations while ensuring compliance with Good Manufacturing Practice (GMP) and regulatory standards.
Key Responsibilities:
* Provide technical expertise, feedback, and guidance on quality assurance and compliance matters, including validation strategies, new product introductions, and manufacturing-related issues, commensurate with the level of risk.
* Manage assigned areas of the Quality Management System (QMS) to ensure product manufacturing aligns with GMP and regulatory standards.
* Oversee QMS elements including deviations, change control, Corrective Action and Preventative Action (CAPA), internal/external audits, customer complaints, vendor management, and the review and approval of manufacturing batch records and production materials.
* Generate, review, and approve Standard Operating Procedures (SOPs) and other documentation related to areas of responsibility.
* Conduct timely review and approval of site procedures and documentation to ensure alignment with GMP and regulatory requirements.
* Review and approve validation protocols, reports, and associated documentation to ensure compliance with EU regulatory standards and internal procedures.
* Maintain documentation schedules to support technology transfers and new product introduction timelines.
* Apply Quality Risk Management principles to all applicable activities.
* Act as Quality Assurance lead on cross-functional project teams involving Operations, Quality Control, Engineering, and other departments.
* Actively contribute to site-wide continuous improvement initiatives.
Requirements:
* Strong understanding of GMP compliance and quality standards.
* Excellent attention to detail with significant experience in document review.
* Proficient in technical writing, including deviation reports and SOPs.
* Strong time management and multitasking abilities.
* Demonstrated ability to drive task completion, resolve issues, and maintain high-quality standards.
* Excellent communication skills, both verbal and written.
* Proficient in written and spoken English.
* Strong team player with a collaborative mindset.
* Third-level qualification in a relevant science or engineering discipline.
* Minimum of 5 years' experience in a GMP-regulated Quality environment.
* Experience in a Validation role with solid knowledge of the project lifecycle and current GMP regulations.