About the Position
This role is responsible for ensuring compliance with quality standards and regulations. The successful candidate will have a strong understanding of EU GMP, US FDA guidelines, and other relevant regulations.
Key Responsibilities
* Coordinating complaint and quality defect reporting systems to ensure prompt and effective resolution.
* Collaborating with internal stakeholders to investigate quality issues and implement corrective actions.
* Identifying and communicating potential quality risks to quality leadership.
* Reviewing and leading investigations to identify root causes and implementing corrective actions.
* Ensuring all investigations are properly documented and CAPAs implemented as necessary.
* Coordinating local regulatory activities, including maintaining the Site Master File.
* Managing supplier quality by conducting audits, reviewing documentation, and generating quality agreements.
* Preparing for site regulatory audits by coordinating readiness programs and managing front room activities.
* Supporting QP certification activities, including batch record review and product specification file maintenance.
Experience/Requirements
* Bachelor's degree in a science or quality-based discipline.
* Minimum 10 years' experience in pharmaceutical finished drug product manufacturing, with working knowledge of EU GMP, US FDA, and other guidelines/regulations.
* Excellent knowledge of current/pending EU GMP and US FDA regulations.
* Strong communication and presentation skills.
* A proven self-starter with advanced organizational skills and attention to detail.
* Ability to work cooperatively with others to establish good working relationships.
Remuneration Package
Salary is negotiable depending on experience.