Job Description
This is a fantastic opportunity to work in a cutting-edge facility with the latest fill-finish and biologics production technology.
Key Responsibilities
* Review and approval of all manufacturing batch documentation, including electronic records and real-time reports, using site systems.
* Review and approval of standard operating procedures (SOPs), cleaning verification/validation data, and other documents for the quality assurance department.
* Develop and maintain accurate operational procedures, training materials, and maintenance guidelines for quality-related systems, ensuring seamless execution.
* Support the development and implementation of enhanced quality reporting metrics.
Requirements
* Relevant experience in quality roles, preferably in pharmaceutical manufacturing environments.
* Knowledge of US and European Good Manufacturing Practices (GMP) guidelines, as well as international regulatory requirements applicable to the site.
* Experience in GMP audits within the pharmaceutical industry.
* Third-level degree in a science or technical discipline.