- Updating Validations SOPS and Masters Plans to ensure compliance to current and future EU/FDA regulations.
- Maintaining an up to date knowledge of relevant regulatory requirements. Interact with other departments to ensure that validation projects are appropriately planned, executed and delivered in a timely manner.
- Approval of SDLC documentation in line with current regulatory and corporate requirements.
- Minimum 3rd level Science /Engineering degree. Minimum 2 years’ experience working in a Validations environment.
- Comprehensive understanding of Validation principles and practices.
- Very good working knowledge of Validations practices, ASTM and relevant EU/FDA regulations.
- A proven track record that demonstrates the ability to work without direct supervision whilst maintaining adherence to project delivery is fundamental to the role.