Position Overview
This role involves coordinating various quality and regulatory activities within a pharmaceutical manufacturing environment. Responsibilities include managing complaint and defect reporting systems, conducting investigations and root cause analyses, and ensuring regulatory compliance through site and supplier management. The candidate will also support audit readiness and certification activities.
Key Responsibilities
1. Coordinate the complaints and quality defect reporting systems.
2. Lead or participate in investigations, agree on CAPA, and communicate issues impacting product quality, safety, efficacy, or compliance to Quality leadership.
3. Review and lead investigations, root cause analysis, and quality risk assessments.
4. Ensure investigations are documented properly with appropriate CAPA actions.
5. Manage local regulatory activities, including updating and maintaining the Site Master File.
6. Oversee the Supplier Quality Management System, including audits, documentation review, and quality agreements.
7. Coordinate site regulatory audit readiness programs and manage audit responses and CAPA.
8. Support QP certification activities such as batch record reviews and product specification maintenance.
Experience and Requirements
* Bachelor’s degree in a science or quality-related discipline.
* At least 10 years of experience in a pharmaceutical finished drug product manufacturing environment.
* Knowledge of EU GMP, US FDA regulations, and other relevant guidelines.
* Strong understanding of current and pending EU GMP and US FDA regulations.
* Excellent verbal and written communication and presentation skills.
* Proven organizational skills and attention to detail.
* Strong interpersonal skills to work effectively with others and maintain good relationships.
Remuneration Package
Salary is negotiable depending on experience.
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