Supervisor, Quality Systems
As a key member of the Quality Systems team, you will lead the daily operations of our Quality Specialists, ensuring their productivity and compliance with both internal and external regulatory standards. This role involves active participation in audits, meticulous preparation of documentation, and maintaining high standards of regulatory compliance.
Key Responsibilities:
- Guide and support QA Specialists in their daily tasks.
- Engage in both internal and external audits, organizing and preparing necessary records.
- Conduct detailed reviews of controlled documents to ensure they meet established standards and resolve any inconsistencies.
- Regularly review regulatory guidelines to ensure ongoing compliance.
- Prepare and submit bi-annual reports to regulatory bodies such as the FDA.
- Develop and maintain detailed product profile folders, managing the entire product lifecycle information.
- Ensure all documentation is well-organized and accessible for regulatory inspections.
Skills and Knowledge:
- In-depth understanding of FDA regulations and industry standards.
- Strong organizational and time-management abilities.
- Proficiency in document management software and Microsoft Office.
Experience and Qualifications:
- Bachelor's degree in a relevant field or equivalent work experience.
- At least five years of experience in a quality systems role within a pharmaceutical manufacturing environment.
By joining our team, you will contribute to providing quality, affordable medication and positively impact the health and well-being of our community. If you are dedicated to quality systems and regulatory compliance, and ready to lead with excellence, we invite you to join us in our mission to produce innovative medications that improve lives.
