Job Title: Quality Assurance Specialist
About the Role:
We are seeking a skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality of our products and services.
Responsibilities:
* 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, CAPA, internal/external audits, customer complaints, vendor management, and the review and approval of manufacturing batch records and production materials.
* Generate, review, and approve 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 QA lead on cross-functional project teams involving Operations, Quality Control, Engineering, and other departments.
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.
What We Offer:
* A dynamic and collaborative work environment.
* Ongoing training and development opportunities.
* A competitive salary and benefits package.