Job Title: GMP Compliance Specialist
Our client is seeking a talented individual to join their team as a GMP Compliance Specialist. This role offers an excellent opportunity to work in a dynamic environment, supporting the qualification and validation of manufacturing operations while ensuring compliance with regulations.
Key Responsibilities:
* Serve as the site point of contact for Quality Assurance activities, providing technical expertise and guidance on QA and compliance matters.
* 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 batch records review.
* 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.
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.