About the Position
* Coordinate Complaints/Quality Defect Reporting Systems.
* Consult with relevant parties and lead/participate in investigations, agreeing appropriate Corrective Action Preventive Action (CAPA).
* Identify and communicate to Quality leadership issues impacting product quality, safety, efficacy, regulatory compliance, or business continuity stemming from suppliers or role-related elements.
* Review/lead Investigations/Root Cause Analysis/Quality Risk Management exercises to ensure documented investigations with relevant CAPA, if necessary.
* Coordinate local regulatory activities, including update/maintenance of the Site Master File.
* Coordinate Supplier Quality Management System, including conducting supplier audits, reviewing supplier documentation, generating/reviewing Quality Agreements, coordinating supplier notification systems, and conducting periodic reviews of suppliers.
* Coordinate site regulatory audit readiness programs, including managing the front room, collating audit responses, agreeing CAPA, etc.
* Support Qualified Person (QP) certification activities, such as batch record review, IMP Order authorization, Product Specification File maintenance, etc.
Experience/Requirements
* Bachelor's degree in a science/quality-based discipline required.
* A minimum of 10 years' experience in a pharmaceutical finished drug product manufacturing environment with working knowledge of EU GMP, US FDA, and other guidelines/regulations.
* Excellent knowledge and understanding of current/pending EU GMP and US FDA regulations.
* Strong communication and presentation skills (verbal/written).
* A proven self-starter with advanced organizational skills and attention to detail.
* Strong people skills, with the ability to work cooperatively and effectively with others to establish and maintain good working relationships.
Remuneration Package
Salary negotiable based on experience.