About the Position
Key Responsibilities:
* Coordinate Complaints / Quality Defect Reporting Systems, Consulting with relevant parties and leading/participating in investigations to agree on appropriate CAPA.
* Identify and communicate issues that may impact product quality, safety, efficacy, regulatory compliance or business continuity.
* Review and lead Investigations / Root Cause Analysis / Quality Risk Management exercises to ensure proper documentation of any such investigations.
* Coordinate local regulatory activities, including Site Master File update/maintenance.
* Implement Supplier Quality Management System by conducting supplier audits, reviewing supplier documentation and generating Quality Agreements.
* Ensure site regulatory audit readiness programs are in place, including managing the front room, collating audit responses and agreeing on CAPA.
* Support QP certification activities such as batch record review and Product Specification File maintenance.
Experience/Requirements
* Bachelor's degree in a science or quality-based discipline required.
* Minimum 10 years' experience in pharmaceutical finished drug product manufacturing environment with EU GMP, US FDA, and other regulations knowledge.
* Strong understanding of current/pending EU GMP and US FDA regulations.
* Excellent communication and presentation skills (verbal/written).
* Proven self-starter with advanced organisational skills and attention to detail.
* Strong people skills for effective collaboration and relationship establishment.
Remuneration Package
Salary negotiable based on experience.