Job Description
We are seeking a skilled Validation Specialist to join our team. As a key member of our operations, you will be responsible for creating and executing validation documentation, coordinating validation activities, and ensuring compliance with regulatory directives.
Responsibilities:
* Create comprehensive validation plans, protocols, reports, and amendments to ensure compliance with Regulatory Agency directives within the Medical Device and Pharma Sector.
* Develop quality documentation in conjunction with validation activities, including process validation, method validation, and process characterization.
* Liaise with cross-functional teams to provide and drive validation inputs into operational activities, promoting a culture of excellence and continuous improvement.
* Develop validation projects, master validation plans, and support policy implementation, ensuring seamless integration with existing processes.
* Ensure ongoing compliance with Good Manufacturing Practice (GMP) in all practices, recording of events, and processes, maintaining high standards of quality and integrity.
* Perform risk assessments and participate in quality audits, identifying areas for improvement and implementing corrective actions.
Requirements:
Skills and Qualifications:
* Bachelor's degree in Engineering or Science discipline.
* A minimum of 3-5 years' experience in Validation or Quality Engineering, with a proven track record of delivering results.
* Strong knowledge of process validation, method validation, and process characterization, as well as validation and quality principles, EudraLex, ISO13485, ISO14644, GAMP5, and FDA regulations.
* Excellent technical report writing, time management, computer, and presentation skills, with the ability to communicate complex ideas effectively.