What are the responsibilities and job description for the Head of Quality Systems and Regulatory Affairs position at Amneal Pharmaceuticals?
About Amneal Pharmaceuticals:
We strive to provide a work environment that is inclusive and diverse. As an equal opportunity employer, we do not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
Job Description:
As a member of our team, you will be responsible for overseeing the management of product recalls, ensuring compliance with regulatory standards and efficient communication across teams. You will also guide the team in Computer System Validation (CSV) efforts, ensuring compliance with CFR Part 11 and effective risk management.
Responsibilities:
We strive to provide a work environment that is inclusive and diverse. As an equal opportunity employer, we do not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
Job Description:
As a member of our team, you will be responsible for overseeing the management of product recalls, ensuring compliance with regulatory standards and efficient communication across teams. You will also guide the team in Computer System Validation (CSV) efforts, ensuring compliance with CFR Part 11 and effective risk management.
Responsibilities:
- Oversee the management of product recalls, ensuring compliance with regulatory standards and efficient communication across teams
- Guide the team in Computer System Validation (CSV) efforts, ensuring compliance with CFR Part 11 and effective risk management
- Collaborate with partners and Contract Manufacturing Organizations (CMOs) to address audit findings and improve compliance
