Job Description
The QA Validation Engineer is responsible for coordinating and implementing the validation process to ensure compliance with client policies, FDA, European cGMP, and GAMP standards. This includes developing and maintaining a site validation program that meets client and regulatory requirements.
Key Responsibilities:
* Develop and maintain a comprehensive validation program to ensure compliance with regulations.
* Coordinate and implement validation protocols and final reports to cGMP standards.
* Validate and quality assure site equipment, utilities, processes, and software in accordance with client policies and regulatory requirements.
* Generate and execute validation plans and reports to meet regulatory expectations.
* Investigate and implement corrective actions to address any validation-related issues.
* Manage validation, exception event, and change control processes to ensure seamless operations.
Requirements:
* Qualification in engineering or scientific discipline.
* Three years of experience in medical device industry with knowledge of cGMP and regulatory requirements.
* Proficiency in creating, reviewing, and approving quality documents and test data.